buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Product NDC
- 58118-1188
- 11-digit product format
- 581181188
- Labeler code
- 58118
- Product ID
- 58118-1188_4c5e6bea-03d2-6813-e063-6294a90aa347
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Clinical Solutions Wholesale, LLC
- 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 | 5Q187997EE, 56W8MW3EN1 |
| Rxcui | 351266, 351267 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58118-1188-8 | buprenorphine hydrochloride and naloxone hydrochloride dihydrate | 30 in 1 BLISTER PACK | TABLET | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58118-1188-8 | 58118118808 | 30 TABLET in 1 BLISTER PACK (58118-1188-8) | 30 tablet | 2026-03-04 | No | No | Historical |