Zolpidem Tartrate
- Product NDC
- 67296-0803
- 11-digit product format
- 672960803
- Labeler code
- 67296
- Product ID
- 67296-0803_8fa98bad-bdd8-444f-abc6-0b864ea000c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RedPharm Drug Inc.
- Application
- ANDA078616
- Marketing category
- ANDA
- Marketing start
- 2008-11-21
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67296-0803-1 | Zolpidem Tartrate | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ZOLPIDEM TARTRATE | ACTIVE INGREDIENT | WY6W63843K | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
| ZOLPIDEM | ACTIVE MOIETY | 7K383OQI23 | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67296-0803 | ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.] | 7 | Legacy NDC, 1 package rows | 20110603_ff6c0109-e6f3-4920-83f3-6e39fd28a118.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 67296-0803-1 | 67296080301 | 10 in 1 BOTTLE | Historical |