Buprenorphine and Naloxone
- Product NDC
- 3215-6523
- 11-digit product format
- 032156523
- Labeler code
- 3215
- Product ID
- 3215-6523_4edfc0c8-bc4c-555f-e063-6294a90a8ca9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine and naloxone
- Dosage form
- FILM
- Route
- BUCCAL; SUBLINGUAL
- Labeler
- Aveva Drug Delivery Systems Inc.
- Application
- ANDA212756
- Marketing category
- ANDA
- Marketing start
- 2023-08-29
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- 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 and Naloxone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | 8 mg/1 |
| NALOXONE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1, F850569PQR |
| 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 |
|---|
| 3215-6523-01 | Buprenorphine and Naloxone | 1 in 1 POUCH | FILM | 1 | | 2 |
| 3215-6523-30 | Buprenorphine and Naloxone | 30 in 1 CARTON | FILM | 30 | | 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 |
|---|
| 3215-6523-01 | 03215652301 | 1 in 1 POUCH | | | | | Historical |
| 3215-6523-30 | 03215652330 | 30 POUCH in 1 CARTON (3215-6523-30) / 1 FILM in 1 POUCH (3215-6523-01) | 30 pouch | 2023-08-29 | No | No | Current |