buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Product NDC
- 0904-7009
- 11-digit product format
- 009047009
- Labeler code
- 0904
- Product ID
- 0904-7009_ed777075-9062-46cb-9911-73c259760849
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA203326
- Marketing category
- ANDA
- Marketing start
- 2014-06-27
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 2; .5 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 | 2 mg/1 |
| NALOXONE HYDROCHLORIDE DIHYDRATE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5Q187997EE, 56W8MW3EN1 |
| Rxcui | 351266, 351267 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7009-06 | buprenorphine hydrochloride and naloxone hydrochloride dihydrate | 1 in 1 BLISTER PACK | TABLET | 1 | | 9 |
| 0904-7009-06 | buprenorphine hydrochloride and naloxone hydrochloride dihydrate | 50 in 1 CARTON | TABLET | 50 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7009 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [MAJOR PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250119_c5fbec69-e7de-44a8-b9fa-0378ae61a9fe.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 |
|---|
| 0904-7009-06 | 00904700906 | 50 BLISTER PACK in 1 CARTON (0904-7009-06) / 1 TABLET in 1 BLISTER PACK | 50 blister pack | 2014-06-27 | 0000-00-00 | No | No | Current |