buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Product NDC
- 71335-1720
- 11-digit product format
- 713351720
- Labeler code
- 71335
- Product ID
- 71335-1720_e8fe83a6-8661-4761-a008-1ec659eb31e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203326
- Marketing category
- ANDA
- Marketing start
- 2014-06-27
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 2; .5 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 hydrochloride and naloxone hydrochloride dihydrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | 2 mg/1 |
| NALOXONE HYDROCHLORIDE DIHYDRATE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1, 5Q187997EE |
| Rxcui | 351266 |
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 |
|---|
| 71335-1720-1 | buprenorphine hydrochloride and naloxone hydrochloride dihydrate | 30 in 1 BOTTLE | TABLET | 30 | | 106 |
| 71335-1720-2 | buprenorphine hydrochloride and naloxone hydrochloride dihydrate | 10 in 1 BOTTLE | TABLET | 10 | | 106 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1720 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [BRYANT RANCH PREPACK] | 105 | Current NDC, Legacy NDC, 2 package rows | 20240824_a0f8c28c-ed9a-4a26-91a3-b996c117ac2c.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 |
|---|
| 71335-1720-1 | 71335172001 | 30 TABLET in 1 BOTTLE (71335-1720-1) | 30 tablet | 2020-10-19 | 0000-00-00 | No | No | Current |
| 71335-1720-2 | 71335172002 | 10 TABLET in 1 BOTTLE (71335-1720-2) | 10 tablet | 2024-08-12 | 0000-00-00 | No | No | Current |