BUPRENORPHINE
- Product NDC
- 72162-1345
- 11-digit product format
- 721621345
- Labeler code
- 72162
- Product ID
- 72162-1345_0c621dd5-d0a5-40f3-910b-e220f46a9a10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPRENORPHINE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207276
- Marketing category
- ANDA
- Marketing start
- 2017-10-25
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BUPRENORPHINE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1 |
| Rxcui | 351265 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72162-1345-3 | BUPRENORPHINE | 30 in 1 BOTTLE | TABLET | 30 | | 107 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-1345 | BUPRENORPHINE TABLET [BRYANT RANCH PREPACK] | 106 | Current NDC, 1 package rows | 20250221_966adb01-71b4-4e0b-bbc6-b83da9987aa2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-1345-3 | 72162134503 | 30 TABLET in 1 BOTTLE (72162-1345-3) | 30 tablet | 2024-04-22 | No | No | Historical |