ZOLPIDEM TARTRATE
- Product NDC
- 61919-528
- 11-digit product format
- 619190528
- Labeler code
- 61919
- Product ID
- 61919-528_05a546cc-4ed6-4466-a288-63ee2e1193d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ZOLPIDEM TARTRATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA078616
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- 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]
- 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 |
|---|
| 61919-528-20 | ZOLPIDEM TARTRATE | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 4 |
| 61919-528-30 | ZOLPIDEM TARTRATE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 61919-528-60 | ZOLPIDEM TARTRATE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
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 [DIRECT RX] | 4 | |
| ZOLPIDEM | ACTIVE MOIETY | 7K383OQI23 | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-528 | ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX] | 4 | Legacy NDC, 3 package rows | 20151110_0ca400d2-4864-43de-bd2f-cda62eb0ab1e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 61919-528-20 | 61919052820 | 20 in 1 BOTTLE | Historical |
| 61919-528-30 | 61919052830 | 30 in 1 BOTTLE | Historical |
| 61919-528-60 | 61919052860 | 60 in 1 BOTTLE | Historical |