Buprenorphine
- Product NDC
- 70518-1557
- 11-digit product format
- 705181557
- Labeler code
- 70518
- Product ID
- 70518-1557_94720b7c-e3d6-8123-e053-2a95a90ab79e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090819
- Marketing category
- ANDA
- Marketing start
- 2018-10-19
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record