pentazocine and naloxone
- Product NDC
- 63304-506
- 11-digit product format
- 633040506
- Labeler code
- 63304
- Product ID
- 63304-506_48ee2bd7-f7c9-4bf8-8932-ba9065c64cf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pentazocine and naloxone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA075523
- Marketing category
- ANDA
- Marketing start
- 2018-07-31
- Substance
- NALOXONE HYDROCHLORIDE; PENTAZOCINE
- Active strength
- .5; 50 mg/1; mg/1
- Pharmacologic classes
- Competitive Opioid Antagonists [MoA], Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- pentazocine and naloxone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALOXONE HYDROCHLORIDE | .5 mg/1 |
| PENTAZOCINE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR, RP4A60D26L |
| Rxcui | 312289 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-506-01 | pentazocine and naloxone | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-506 | PENTAZOCINE AND NALOXONE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20180731_41ebdaaf-3bbc-419f-b996-0341efc14623.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 |
|---|
| 63304-506-01 | 63304050601 | 100 TABLET in 1 BOTTLE (63304-506-01) | 100 tablet | 2018-07-31 | 0000-00-00 | No | No | Current |