Buprenorphine
- Product NDC
- 71335-0353
- 11-digit product format
- 713350353
- Labeler code
- 71335
- Product ID
- 71335-0353_2369cc02-12e9-45f7-bc13-78fa7e0c7c5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090819
- Marketing category
- ANDA
- Marketing start
- 2015-02-19
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-0353-1 | 71335035301 | 60 TABLET in 1 BOTTLE (71335-0353-1) | 60 tablet | 2017-04-26 | 0000-00-00 | No | No | Current |
| 71335-0353-2 | 71335035302 | 90 TABLET in 1 BOTTLE (71335-0353-2) | 90 tablet | 2022-05-02 | 0000-00-00 | No | No | Current |
| 71335-0353-3 | 71335035303 | 30 TABLET in 1 BOTTLE (71335-0353-3) | 30 tablet | 2022-05-02 | 0000-00-00 | No | No | Current |
| 71335-0353-4 | 71335035304 | 7 TABLET in 1 BOTTLE (71335-0353-4) | 7 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0353-5 | 71335035305 | 28 TABLET in 1 BOTTLE (71335-0353-5) | 28 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0353-6 | 71335035306 | 1 TABLET in 1 BOTTLE (71335-0353-6) | 1 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0353-7 | 71335035307 | 12 TABLET in 1 BOTTLE (71335-0353-7) | 12 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0353-8 | 71335035308 | 120 TABLET in 1 BOTTLE (71335-0353-8) | 120 tablet | 2022-05-02 | 0000-00-00 | No | No | Current |