Buprenorphine and Naloxone
- Product NDC
- 43598-580
- 11-digit product format
- 435980580
- Labeler code
- 43598
- Product ID
- 43598-580_af3c8314-5a38-2103-6ef8-94f179ffd541
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- FILM, SOLUBLE
- Route
- BUCCAL; SUBLINGUAL
- Labeler
- Dr.Reddys Laboratories Inc
- Application
- ANDA205806
- Marketing category
- ANDA
- Marketing start
- 2018-06-14
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE
- 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1, 36B82AMQ7N |
| Rxcui | 1307056, 1307061 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-580-01 | Buprenorphine and Naloxone | 1 in 1 POUCH | FILM, SOLUBLE | 1 | | 11 |
| 43598-580-30 | Buprenorphine and Naloxone | 30 in 1 CARTON | FILM, SOLUBLE | 30 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-580 | BUPRENORPHINE AND NALOXONE FILM, SOLUBLE [DR.REDDYS LABORATORIES INC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240125_72dc1ec0-7c59-a587-4ffd-c40ef79e6fb2.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 |
|---|
| 43598-580-01 | 43598058001 | 1 in 1 POUCH | | | | | | Historical |
| 43598-580-30 | 43598058030 | 30 POUCH in 1 CARTON (43598-580-30) / 1 FILM, SOLUBLE in 1 POUCH (43598-580-01) | 30 pouch | 2018-06-14 | 0000-00-00 | No | No | Current |