Buprenorphine and Naloxone
- Product NDC
- 71335-1296
- 11-digit product format
- 713351296
- Labeler code
- 71335
- Product ID
- 71335-1296_9edc1edc-dc15-456c-b48f-aebe63540b31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205022
- Marketing category
- ANDA
- Marketing start
- 2016-09-19
- Substance
- BUPRENORPHINE; NALOXONE
- Active strength
- 2; .5 mg/1; mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-1296_9edc1edc-dc15-456c-b48f-aebe63540b31
- SPL ID
- 9edc1edc-dc15-456c-b48f-aebe63540b31
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Buprenorphine and Naloxone
- Generic name
- Buprenorphine and Naloxone
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Marketing start
- 2016-09-19
- Marketing category
- ANDA
- Application number
- ANDA205022
- Pharmacologic classes
- Opioid Antagonist [EPC]; Opioid Antagonists [MoA]; Partial Opioid Agonist [EPC]; Partial Opioid Agonists [MoA]
- DEA schedule
- CIII
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| BUPRENORPHINE | 2 mg/1 |
| NALOXONE | .5 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 40D3SCR4GZ, 36B82AMQ7N |
| Rxcui | 351266 |
| Spl Set Id | fc2755a5-3292-4b49-872d-e22c386a4e44 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-1296-1 | 30 TABLET in 1 BOTTLE (71335-1296-1) | 2019-08-12 | No |
| 71335-1296-2 | 10 TABLET in 1 BOTTLE (71335-1296-2) | 2024-05-17 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 40D3SCR4GZ | BUPRENORPHINE | 52485-79-7 | BUPRENORPHINE |
| 36B82AMQ7N | NALOXONE | 465-65-6 | NALOXONE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1296-1 | 71335129601 | 30 TABLET in 1 BOTTLE (71335-1296-1) | 30 tablet | 2019-08-12 | No | No | Historical |
| 71335-1296-2 | 71335129602 | 10 TABLET in 1 BOTTLE (71335-1296-2) | 10 tablet | 2024-05-17 | No | No | Historical |