Buprenorphine
- Product NDC
- 0904-7154
- 11-digit product format
- 009047154
- Labeler code
- 0904
- Product ID
- 0904-7154_d28a45db-8ce9-4eef-91ad-2ed508956e59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA078633
- Marketing category
- ANDA
- Marketing start
- 2009-10-08
- 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
- 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 | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1 |
| Rxcui | 351264, 351265 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7154-04 | Buprenorphine | 30 in 1 CARTON | TABLET | 30 | | 9 |
| 0904-7154-04 | Buprenorphine | 1 in 1 BLISTER PACK | TABLET | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7154 | BUPRENORPHINE HCL TABLET [MAJOR PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250402_dba586f9-e3f2-4b9c-849b-907c81a5a0ef.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-7154-04 | 00904715404 | 30 BLISTER PACK in 1 CARTON (0904-7154-04) / 1 TABLET in 1 BLISTER PACK | 30 blister pack | 2009-10-08 | 0000-00-00 | No | No | Current |