Zolpidem Tartrate
- Product NDC
- 0093-0073
- 11-digit product format
- 000930073
- Labeler code
- 0093
- Product ID
- 0093-0073_2d5139eb-e369-43f7-951b-666cf006ba33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA076410
- Marketing category
- ANDA
- Marketing start
- 2007-04-23
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
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 [TEVA PHARMACEUTICALS USA INC] | 10 | |
| ZOLPIDEM | ACTIVE MOIETY | 7K383OQI23 | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 10 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 10 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 10 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 10 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 10 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 10 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 10 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 10 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 10 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-0073 | ZOLPIDEM TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 22 | Legacy NDC | 20250226_c784cf9d-de8f-44b6-b52f-a0e7c0d35e48.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-0073-01 | 00093007301 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-0073-01) | 2007-04-23 | 0000-00-00 | No | No | Current |