Zolpidem Tartrate
- Product NDC
- 68084-189
- 11-digit product format
- 680840189
- Labeler code
- 68084
- Product ID
- 68084-189_ea3cbeb8-36c0-f24f-e053-2995a90a9bd9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA077322
- Marketing category
- ANDA
- Marketing start
- 2013-12-27
- 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ZOLPIDEM TARTRATE | ACTIVE INGREDIENT | WY6W63843K | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| ZOLPIDEM | ACTIVE MOIETY | 7K383OQI23 | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-189 | ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 10 | Legacy NDC | 20241003_752c0ee4-5bb8-4316-9e9d-e6e6802797ba.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-189-01 | 68084018901 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-189-01) > 1 TABLET, COATED in 1 BLISTER PACK (68084-189-11) | 100 blister pack | 2013-12-27 | 0000-00-00 | No | No | Current |