BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
- Product NDC
- 67296-2191
- 11-digit product format
- 672962191
- Labeler code
- 67296
- Product ID
- 67296-2191_490df063-a9d0-7d96-e063-6394a90a1e15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Redpharm Drug
- Application
- ANDA209069
- Marketing category
- ANDA
- Marketing start
- 2020-09-01
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 8; 2 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | 8 mg/1 |
| NALOXONE HYDROCHLORIDE DIHYDRATE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1, 5Q187997EE |
| Rxcui | 351267 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67296-2191-1 | BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE | 12 in 1 BOTTLE, PLASTIC | TABLET | 12 | | 2 |
| 67296-2191-6 | BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE | 6 in 1 BOTTLE, PLASTIC | TABLET | 6 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67296-2191-1 | 67296219101 | 12 TABLET in 1 BOTTLE, PLASTIC (67296-2191-1) | 12 tablet | 2020-09-01 | No | No | Current |
| 67296-2191-6 | 67296219106 | 6 TABLET in 1 BOTTLE, PLASTIC (67296-2191-6) | 6 tablet | 2020-09-01 | No | No | Current |