Buprenorphine and Naloxone
- Product NDC
- 53217-138
- 11-digit product format
- 532170138
- Labeler code
- 53217
- Product ID
- 53217-138_7511903e-4f5d-4fc3-8d82-08eca9a9c67b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride and naloxone hydrochloride
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA204431
- Marketing category
- ANDA
- Marketing start
- 2015-12-10
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 53217-138-30 | Buprenorphine and Naloxone | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-138 | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 1 package rows | 20161206_fb7e9780-2576-4a0d-afa0-d0ce0c1dcad2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-138-30 | 53217013830 | 30 in 1 BOTTLE | Historical |