buprenorphine hydrochloride
- Product NDC
- 70518-4571
- 11-digit product format
- 705184571
- Labeler code
- 70518
- Product ID
- 70518-4571_4a90c80f-32a9-ea0d-e063-6394a90aae6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090622
- Marketing category
- ANDA
- Marketing start
- 2026-02-10
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1 |
| Rxcui | 351265 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4571-0 | buprenorphine hydrochloride | 30 in 1 BOX | TABLET | 30 | | 1 |
| 70518-4571-1 | buprenorphine hydrochloride | 1 in 1 POUCH | TABLET | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4571-0 | 70518457100 | 30 POUCH in 1 BOX (70518-4571-0) / 1 TABLET in 1 POUCH (70518-4571-1) | 30 pouch | 2026-02-10 | No | No | Historical |
| 70518-4571-1 | 70518457101 | 1 in 1 POUCH | | | | | Historical |