Zolpidem Tartrate
- Product NDC
- 10544-540
- 11-digit product format
- 105440540
- Labeler code
- 10544
- Product ID
- 10544-540_11a76fc1-5a20-0509-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA078616
- Marketing category
- ANDA
- Marketing start
- 2013-10-03
- 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 |
|---|
| 10544-540-30 | Zolpidem Tartrate | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
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 [BLENHEIM PHARMACAL, INC.] | 1 | |
| ZOLPIDEM | ACTIVE MOIETY | 7K383OQI23 | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-540 | ZOLPIDEM TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 1 package rows | 20150319_11a7a0c7-d5c6-0839-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-540-30 | 10544054030 | 30 in 1 BOTTLE, PLASTIC | Historical |