Buprenorphine and Naloxone
- Product NDC
- 0378-8766
- 11-digit product format
- 003788766
- Labeler code
- 0378
- Product ID
- 0378-8766_008d89ec-5bd7-46d9-bc94-9cdc7405f95d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- FILM
- Route
- BUCCAL; SUBLINGUAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA211785
- Marketing category
- ANDA
- Marketing start
- 2020-04-17
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 4; 1 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 and Naloxone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | 4 mg/1 |
| NALOXONE HYDROCHLORIDE DIHYDRATE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1, 5Q187997EE |
| Rxcui | 1010600, 1010604, 1307056, 1307061 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-8766-16 | Buprenorphine and Naloxone | 1 in 1 POUCH | FILM | 1 | | 12 |
| 0378-8766-93 | Buprenorphine and Naloxone | 30 in 1 CARTON | FILM | 30 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-8766 | BUPRENORPHINE AND NALOXONE FILM [MYLAN PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240418_557d8d4d-8751-431c-b18e-9d5cf23fc579.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 |
|---|
| 0378-8766-16 | 00378876616 | 1 in 1 POUCH | | | | | | Historical |
| 0378-8766-93 | 00378876693 | 30 POUCH in 1 CARTON (0378-8766-93) / 1 FILM in 1 POUCH (0378-8766-16) | 30 pouch | 2020-04-17 | 0000-00-00 | No | No | Current |