Buprenorphine and Naloxone
- Product NDC
- 63629-9482
- 11-digit product format
- 636299482
- Labeler code
- 63629
- Product ID
- 63629-9482_56ec45bc-f40b-415f-874c-640a991faca9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205601
- Marketing category
- ANDA
- Marketing start
- 2020-04-13
- 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
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 63629-9482_56ec45bc-f40b-415f-874c-640a991faca9
- SPL ID
- 56ec45bc-f40b-415f-874c-640a991faca9
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Buprenorphine and Naloxone
- Generic name
- Buprenorphine and Naloxone
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Marketing start
- 2020-04-13
- Marketing category
- ANDA
- Application number
- ANDA205601
- 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 | 2 mg/1 |
| NALOXONE HYDROCHLORIDE DIHYDRATE | .5 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 56W8MW3EN1, 5Q187997EE |
| Rxcui | 351266 |
| Spl Set Id | dd6e4fc9-a6f7-458a-b075-d736ce8b7172 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 63629-9482-1 | 30 TABLET in 1 BOTTLE, PLASTIC (63629-9482-1) | 2022-12-12 | No |
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 | Sample | Exclude flag | Status |
|---|
| 63629-9482-1 | 63629948201 | 30 TABLET in 1 BOTTLE, PLASTIC (63629-9482-1) | 30 tablet | 2022-12-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Buprenorphine and Naloxone | Bryant Ranch Prepack | 2024-08-14 | HUMAN PRESCRIPTION DRUG LABEL | 105 |