Products covered under the ER/LA Opioid Analgesics REMS Program

Brand Name Products

Trade Name Generic Name Company Contact Links
Trade Name
Arymo® ER
Generic Name
(morphine sulfate) extended-release tablets, for oral use CII
Company
Egalet Corporation
Contact
1-800-518-1084
Links
Trade Name
Belbuca®
Generic Name
Buprenorphine buccal film
Company
BioDelivery Sciences International, Inc (BDSI)
Contact
1-877-579-4578
Links
Trade Name
Butrans®
Generic Name
Buprenorphine transdermal system
Company
Purdue Pharma L.P.
Contact
1-888-726-7535
Links
Trade Name
Dolophine®
Generic Name
Methadone hydrochloride tablets
Company
Hikma Pharmaceuticals USA Inc.
Contact
1-800-962-8364
Links
Trade Name
Duragesic®
Generic Name
Fentanyl transdermal system
Company
Janssen Pharmaceuticals, Inc.
Contact
1-800-526-7736
Links
Trade Name
Embeda®
Generic Name
Morphine sulfate and naltrexone extended-release capsules
Company
Pfizer Inc.
Contact
1-800-438-1985
Links
Trade Name
EXALGO®
Generic Name
Hydromorphone hydrochloride extended-release tablets
Company
SpecGx LLC
Contact
1-800-778-7898
Links
Trade Name
Hysingla ER
Generic Name
Hydrocodone bitartrate extended-release tablets
Company
Purdue Pharma L.P.
Contact
1-888-726-7535
Links
Trade Name
Kadian®
Generic Name
Morphine sulfate extended-release capsules
Company
Allergan Sales, LLC
Contact
1-862-261-7000
Links
Trade Name
MorphaBond ER
Generic Name
Morphine sulfate tablet, extended release
Company
Daiichi Sankyo, Inc.
Contact
1-877-437-7763
Links
Trade Name
MS Contin®
Generic Name
Morphine sulfate extended-release tablets
Company
Purdue Pharma L.P.
Contact
1-888-726-7535
Links
Trade Name
Nucynta® ER
Generic Name
Tapentadol extended-release oral tablets
Company
Depomed
Contact
1-866-458-6389
Links
Trade Name
Opana® ER
Generic Name
Oxymorphone hydrochloride extended-release tablets
Company
Endo Pharmaceuticals Inc.
Contact
1-800-462-3636
Links
Trade Name
OxyContin®
Generic Name
Oxycodone hydrochloride extended-release tablets
Company
Purdue Pharma L.P.
Contact
1-888-726-7535
Links
Trade Name
*Targiniq® ER
Generic Name
Oxycodone hydrochloride and naloxone hydrochloride extended-release tablets
Company
Purdue Pharma L.P.
Contact
1-888-726-7535
Links
Trade Name
Xartemis® XR
Generic Name
Oxycodone hydrochloride and acetaminophen extended-release tablets
Company
Mallinckrodt LLC
Contact
1-800-778-7898
Links
Trade Name
XTAMPZA® ER
Generic Name
Oxycodone extended-release capsules
Company
Collegium Pharmaceutical, Inc.
Contact
1-781-713-3699
Links
Trade Name
Zohydro® ER
Generic Name
Hydrocodone bitartrate extended-release capsules
Company
Pernix Ireland Pain Designated Activity Company
Contact
1-877-745-3667
Links
*Approved, but not currently marketed.

Generic Products

Drug Name Generic Name Company Contact Links
Drug Name
Fentanyl
Generic Name
Fentanyl transdermal system
Company
Mylan Technologies, Inc.
Contact
1-877-446-3679
Links
Drug Name
Fentanyl
Generic Name
Fentanyl Transdermal system
Company
3 M Drug Delivery Systems
Contact
1-866-770-3024
Links
Drug Name
Fentanyl
Generic Name
Fentanyl transdermal system
Company
Teva Pharmaceuticals USA, Inc.
Contact
1-800-272-5525
Links
Drug Name
Fentanyl
Generic Name
Fentanyl transdermal system
Company
Aveva Drug Delivery Systems, Inc. a subsidiary of Apotex (marketed by Apotex Corp.)
Contact
1-888-333-6127
Links
Drug Name
Fentanyl
Generic Name
Fentanyl transdermal system
Company
SpecGx LLC
Contact
1-800-778-7898
Links
Drug Name
Fentanyl
Generic Name
Fentanyl transdermal system
Company
Mayne Pharma
Contact
1-844-825-8500
Links
  • U.S. Prescribing Information
    (Coming Soon)
  • Medication Guide
    (Coming Soon)
Drug Name
Fentanyl
Generic Name
Fentanyl transdermal system
Company
Sandoz Inc.
Contact
1-800-525-8747
Links
Drug Name
Hydromorphone Hydrochloride
Generic Name
Hydromorphone Hydrochloride Extended-release Tablets
Company
Paddock Laboratories, LLC, subsidiary of Perrigo Company PLC
Contact
1-866-634-9120
Links
Drug Name
Hydromorphone Hydrochloride Extended-release Tablets
Generic Name
Hydromorphone Hydrochloride Extended-release Tablets
Company
Teva Pharmaceuticals USA, Inc.
Contact
1-800-272-5525
Links
Drug Name
Hydromorphone Hydrochloride Extended-release Tablets
Generic Name
Hydromorphone Hydrochloride Extended-release Tablets
Company
Osmotica Pharmaceutical US LLC
Contact
1-908-809-1300
Links
Drug Name
Hydromorphone Hydrochloride Extended-release Tablets (AG for EXALGO)
Generic Name
Hydromorphone Hydrochloride Extended-release Tablets
Company
SpecGx LLC
Contact
1-800-778-7898
Links
Drug Name
Hydromorphone Hydrochloride, USP
Generic Name
Hydromorphone Hydrochloride Tablets
Company
Elite Laboratories Inc.
Contact
1-888-852-6657
Links
Drug Name
Methadone
Generic Name
Methadone
Company
Elite Laboratories Inc.
Contact
1-888-852-6657
Links
Drug Name
Methadone Hydrochloride
Generic Name
Methadone hydrochloride Intensol oral concentrate
Company
Hikma Pharmaceuticals USA Inc.
Contact
1-800-962-8364
Links
Drug Name
Methadone Hydrochloride
Generic Name
Methadone hydrochloride oral solution
Company
Hikma Pharmaceuticals USA Inc.
Contact
1-800-962-8364
Links
Drug Name
Methadone Hydrochloride
Generic Name
Methadone hydrochloride oral solution
Company
VistaPharm, Inc.
Contact
1-888-655-1505
Links
Drug Name
Methadone Hydrochloride
Generic Name
Methadone Hydrochloride Tablets
Company
Aurolife Pharma LLC
Contact
1-866-850-2876
Links
Drug Name
Methadone Hydrochloride
Generic Name
Methadone hydrochloride tablets
Company
SpecGx LLC
Contact
1-800-778-7898
Links
Drug Name
Methadone Hydrochloride
Generic Name
Methadone Hydrochloride Tablet for Oral Suspension (orange flavored)
Company
SpecGx LLC
Contact
1-800-778-7898
Links
Drug Name
Methadone Hydrochloride
Generic Name
Methadone hydrochloride tablets
Company
Hikma Pharmaceuticals USA Inc.
Contact
1-800-962-8364
Links
Drug Name
Methadone Hydrochloride
Generic Name
Methadone hydrochloride tablets
Company
Sandoz Inc.
Contact
1-800-525-8747
Links
Drug Name
Methadone Hydrochloride
Generic Name
Methadone Hydrochloride Tablets
Company
Sun Pharmaceutical Industries, Inc.
Contact
1-800-406-7984
Links
Drug Name
Methadone Hydrochloride
Generic Name
Methadone hydrochloride tablets
Company
ThePharmaNetwork, LLC
Contact
1-877-272-7901
Links
Drug Name
Methadose
Generic Name
Methadone hydrochloride tablets
Company
SpecGx LLC
Contact
1-800-778-7898
Links
Drug Name
Morphine Sulfate
Generic Name
Morphine sulfate capsule, extended-release
Company
Upsher-Smith Laboratories, LLC
Contact
1-800-654-2299
Links
Drug Name
Morphine Sulfate (generic for Avinza)
Generic Name
Morphine sulfate extended-release capsules
Company
Teva Pharmaceuticals USA, Inc.
Contact
1-800-432-8534
Links
Drug Name
Morphine Sulfate (AG for Kadian)
Generic Name
Morphine sulfate extended-release capsules
Company
Teva Pharmaceuticals USA, Inc.
Contact
1-800-432-8534
Links
Drug Name
Morphine Sulfate
Generic Name
Morphine sulfate extended-release tablets
Company
SpecGx LLC
Contact
1-800-778-7898
Links
Drug Name
Morphine Sulfate
Generic Name
Morphine sulfate extended-release tablets
Company
Mayne Pharma
Contact
1-844-825-8500
Links
Drug Name
Morphine Sulfate
Generic Name
Morphine sulfate extended-release tablets
Company
Mylan Pharmaceuticals Inc.
Contact
1-877-446-3679
Links
Drug Name
Morphine Sulfate
Generic Name
Morphine Sulfate extended-release tablets
Company
Nesher Pharmaceuticals (USA) LLC
Contact
1-314-209-4700
Links
Drug Name
Morphine Sulfate
Generic Name
Morphine sulfate extended-release capsules
Company
Par Pharmaceutical, Inc.
Contact
1-800-828-9393
Links
Drug Name
Morphine Sulfate
Generic Name
Morphine sulfate extended-release tablets
Company
Par Pharmaceutical, Inc.
Contact
1-800-828-9393
Links
Drug Name
Morphine Sulfate
Generic Name
Morphine Sulfate Extended-Release Tablets
Company
Sun Pharmaceutical Industries, Inc.
Contact
1-800-406-7984
Links
Drug Name
Morphine Sulfate
Generic Name
Morphine sulfate extended-release tablets
Company
Rhodes Pharmaceuticals L.P.
Contact
1-888-827-0616
Links
Drug Name
Morphine Sulfate
Generic Name
Morphine Sulfate, Extended Release, Capsules
Company
Impax (marketed by Global Pharmaceuticals, division of Impax)
Contact
1-877-994-6729 Option 2
Links
Drug Name
Morphine Sulfate Extended-release Tablets
Generic Name
Morphine Sulfate Extended-release Tablets
Company
Teva Pharmaceuticals USA, Inc.
Contact
1-800-432-8534
Links
Drug Name
Morphine Sulfate Extended-Release Tablets
Generic Name
Morphine sulfate extended-release tablets
Company
Novel Laboratories, Inc.
Contact
1-866-403-7592
Links
Drug Name
Oxycodone Hydrochloride (AG for OxyContin)
Generic Name
Oxycodone Hydrochloride Extended-Release Tablets
Company
Ranbaxy Pharmaceuticals, Inc. (AG for Purdue Pharma)
Contact
1-800-406-7984
Links
Drug Name
Oxycodone hydrochloride (AG for OxyContin)
Generic Name
Oxycodone hydrochloride extended-release tablets
Company
Teva Pharmaceuticals USA, Inc.
Contact
1-800-272-5525
Links
Drug Name
Oxycodone hydrochloride (AG for OxyContin)
Generic Name
Oxycodone Hydrochloride Extended-Release Tablets
Company
Par Pharmaceutical, Inc.
Contact
1-800-828-9393
Links
Drug Name
Oxymorphone Hydrochloride
Generic Name
Oxymorphone hydrochloride extended-release tablets
Company
Teva Pharmaceuticals USA, Inc.
Contact
1-800-432-8534
Links
Drug Name
Oxymorphone Hydrochloride
Generic Name
Oxymorphone hydrochloride extended-release tablets
Company
Impax (marketed by Global Pharmaceuticals, division of Impax)
Contact
1-877-994-6729 Option 2
Links
Drug Name
Oxymorphone Hydrochloride
Generic Name
Oxymorphone Hydrochloride Extended-release Tablets
Company
SpecGx LLC
Contact
1-800-778-7898
Links
Drug Name
*Oxymorphone Hydrochloride
Generic Name
Oxymorphone hydrochloride extended-release tablets
Company
Hikma Pharmaceuticals USA Inc.
Contact
1-800-962-8364
Links
  • U.S. Prescribing Information
    (Coming Soon)
  • Medication Guide
    (Coming Soon)
Drug Name
Tramadol Hydrochloride Extended-Release Tablets
Generic Name
Tramadol Hydrochloride Extended-Release Tablets
Company
Lupin Pharmaceuticals Inc.
Contact
1-800-399-2561
Links
*Approved, but not currently marketed