BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
- Product NDC
- 71335-1858
- 11-digit product format
- 713351858
- Labeler code
- 71335
- Product ID
- 71335-1858_9bc52e26-1d52-4d68-894a-d3b300f5f090
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209069
- Marketing category
- ANDA
- Marketing start
- 2021-01-22
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- 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
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-1858_9bc52e26-1d52-4d68-894a-d3b300f5f090
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
- Generic name
- BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Marketing start
- 2021-01-22
- Marketing category
- ANDA
- Application number
- ANDA209069
- Pharmacologic classes
- Opioid Antagonist [EPC]; Opioid Antagonists [MoA]; Partial Opioid Agonist [EPC]; Partial Opioid Agonists [MoA]
- DEA schedule
- CIII
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | 8 mg/1 |
| NALOXONE HYDROCHLORIDE DIHYDRATE | 2 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 56W8MW3EN1, 5Q187997EE |
| Rxcui | 351267 |
| Spl Set Id | 53457b0d-3462-489e-8cf5-7cdc2ecffb48 |
| Manufacturer Name | Bryant Ranch Prepack |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 56W8MW3EN1 | BUPRENORPHINE HYDROCHLORIDE | 53152-21-9 | BUPRENORPHINE HYDROCHLORIDE |
| 5Q187997EE | NALOXONE HYDROCHLORIDE DIHYDRATE | 51481-60-8 | NALOXONE HYDROCHLORIDE DIHYDRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1858-0 | 71335185800 | 42 TABLET in 1 BOTTLE, PLASTIC (71335-1858-0) | 42 tablet | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-1858-1 | 71335185801 | 30 TABLET in 1 BOTTLE, PLASTIC (71335-1858-1) | 30 tablet | 2021-05-07 | 0000-00-00 | No | No | Current |
| 71335-1858-2 | 71335185802 | 60 TABLET in 1 BOTTLE, PLASTIC (71335-1858-2) | 60 tablet | 2021-06-08 | 0000-00-00 | No | No | Current |
| 71335-1858-3 | 71335185803 | 90 TABLET in 1 BOTTLE, PLASTIC (71335-1858-3) | 90 tablet | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-1858-4 | 71335185804 | 120 TABLET in 1 BOTTLE, PLASTIC (71335-1858-4) | 120 tablet | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-1858-5 | 71335185805 | 14 TABLET in 1 BOTTLE, PLASTIC (71335-1858-5) | 14 tablet | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-1858-6 | 71335185806 | 28 TABLET in 1 BOTTLE, PLASTIC (71335-1858-6) | 28 tablet | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-1858-7 | 71335185807 | 6 TABLET in 1 BOTTLE, PLASTIC (71335-1858-7) | 6 tablet | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-1858-8 | 71335185808 | 10 TABLET in 1 BOTTLE, PLASTIC (71335-1858-8) | 10 tablet | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-1858-9 | 71335185809 | 21 TABLET in 1 BOTTLE, PLASTIC (71335-1858-9) | 21 tablet | 2022-02-14 | 0000-00-00 | No | No | Current |