Buprenorphine and Naloxone
- Product NDC
- 67296-1933
- 11-digit product format
- 672961933
- Labeler code
- 67296
- Product ID
- 67296-1933_46e93923-334d-68db-e063-6394a90ad902
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- FILM
- Route
- BUCCAL; SUBLINGUAL
- Labeler
- Redpharm Drug
- Application
- ANDA205954
- Marketing category
- ANDA
- Marketing start
- 2019-02-11
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Buprenorphine and Naloxone
- Brand name suffix
- Sublingual Film
- Listing expiration
- 2026-12-31
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 | 1010604 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67296-1933-1 | Buprenorphine and NaloxoneSublingual Film | 1 in 1 POUCH | FILM | 1 | | 4 |
| 67296-1933-1 | Buprenorphine and NaloxoneSublingual Film | 1 in 1 CARTON | FILM | 1 | | 4 |
| 67296-1933-9 | Buprenorphine and NaloxoneSublingual Film | 9 in 1 CARTON | FILM | 9 | | 4 |
| 67296-1933-9 | Buprenorphine and NaloxoneSublingual Film | 1 in 1 POUCH | FILM | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67296-1933 | BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM (BUPRENORPHINE AND NALOXONE) FILM [REDPHARM DRUG] | 2 | Current NDC, 4 package rows | 20250309_2fd16916-95a9-14b5-e063-6294a90a79fa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67296-1933-1 | 67296193301 | 1 POUCH in 1 CARTON (67296-1933-1) / 1 FILM in 1 POUCH | 1 pouch | 2019-02-11 | No | No | Current |
| 67296-1933-9 | 67296193309 | 9 POUCH in 1 CARTON (67296-1933-9) / 1 FILM in 1 POUCH | 9 pouch | 2019-02-11 | No | No | Current |