BUPRENORPHINE
- Product NDC
- 63629-9475
- 11-digit product format
- 636299475
- Labeler code
- 63629
- Product ID
- 63629-9475_0528c316-c40e-4d8e-bb5e-2663faf8a307
- 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
- 2 mg/1
- Pharmacologic classes
- 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
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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-9475-1 | BUPRENORPHINE | 30 in 1 BOTTLE | TABLET | 30 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-9475 | BUPRENORPHINE TABLET [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 1 package rows | 20240821_bc5a7137-9e8f-438e-84d9-bdbf1db12998.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 |
|---|
| 63629-9475-1 | 63629947501 | 30 TABLET in 1 BOTTLE (63629-9475-1) | 30 tablet | 2022-11-28 | 0000-00-00 | No | No | Current |