Buprenorphine and Naloxone
- Product NDC
- 47781-356
- 11-digit product format
- 477810356
- Labeler code
- 47781
- Product ID
- 47781-356_cf48e146-c279-72ae-6437-005aeea86e46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- FILM
- Route
- BUCCAL; SUBLINGUAL
- Labeler
- Alvogen Inc.
- Application
- ANDA205954
- Marketing category
- ANDA
- Marketing start
- 2019-02-11
- 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
- Brand name suffix
- Sublingual Film
- 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 | 5Q187997EE, 56W8MW3EN1 |
| Rxcui | 1010600, 1010604, 1307056, 1307061 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47781-356-03 | Buprenorphine and Naloxone Sublingual Film | 30 in 1 CARTON | FILM | 30 | | 19 |
| 47781-356-11 | Buprenorphine and Naloxone Sublingual Film | 1 in 1 POUCH | FILM | 1 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47781-356 | BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM (BUPRENORPHINE AND NALOXONE ) FILM [ALVOGEN INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20240215_4210afeb-474c-d842-d68e-af7e0021851a.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 |
|---|
| 47781-356-03 | 47781035603 | 30 POUCH in 1 CARTON (47781-356-03) / 1 FILM in 1 POUCH (47781-356-11) | 30 pouch | 2019-02-11 | 0000-00-00 | No | No | Current |
| 47781-356-11 | 47781035611 | 1 in 1 POUCH | | | | | | Historical |