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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Buprenorphine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Status |
|---|
| 70518-1557-1 | 70518155701 | 50 POUCH in 1 BOX (70518-1557-1) / 1 TABLET in 1 POUCH (70518-1557-2) | 50 pouch | 2026-07-07 | 0 | Current |