Buprenorphine Hydrochloride
- Product NDC
- 0143-9246
- 11-digit product format
- 001439246
- Labeler code
- 0143
- Product ID
- 0143-9246_8ba9787c-d429-4a5d-8424-e13be15cb9f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA076931
- Marketing category
- ANDA
- Marketing start
- 2005-05-25
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- .324 mg/mL
- 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 Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | .324 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1 |
| Rxcui | 238129 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9246-01 | Buprenorphine Hydrochloride | 1 mL in 1 VIAL | INJECTION | 1 | | 8 |
| 0143-9246-05 | Buprenorphine Hydrochloride | 5 in 1 CARTON | INJECTION | 5 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9246 | BUPRENORPHINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250316_adc1167e-910e-4d7b-abdc-751d3df0c3dc.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 |
|---|
| 0143-9246-01 | 00143924601 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 0143-9246-05 | 00143924605 | 5 VIAL in 1 CARTON (0143-9246-05) / 1 mL in 1 VIAL (0143-9246-01) | 5 vial | 2019-07-12 | 0000-00-00 | No | No | Current |