Zolpidem Tartrate
- Product NDC
- 43353-727
- 11-digit product format
- 433530727
- Labeler code
- 43353
- Product ID
- 43353-727_492080ed-6710-4c22-987b-197c7301a509
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA021774
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2010-12-06
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 13 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
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
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, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| zolpidem | ACTIVE MOIETY | 7K383OQI23 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FD&C Blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| potassium bitartrate | INACTIVE INGREDIENT | NPT6P8P3UU | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-727 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] | 4 | Legacy NDC | 20240405_19622c86-72c1-46a6-b889-ee1f7cbd4665.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-727-30 | 43353072730 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-727-30) | 2011-05-14 | 0000-00-00 | No | No | Current |
| 43353-727-60 | 43353072760 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-727-60) | 2011-10-16 | 0000-00-00 | No | No | Current |