Zolpidem Tartrate
- Product NDC
- 0955-1702
- 11-digit product format
- 009551702
- Labeler code
- 0955
- Product ID
- 0955-1702_b1f2cfd0-f270-4a33-9232-2a3aee6781db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Winthrop U.S.
- Application
- NDA021774
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2010-10-14
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 6 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0955-1702-10 | Zolpidem Tartrate | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 17 |
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 [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
| zolpidem | ACTIVE MOIETY | 7K383OQI23 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
| FD&C Blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
| potassium bitartrate | INACTIVE INGREDIENT | NPT6P8P3UU | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0955-1702 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [SANOFI-AVENTIS U.S. LLC] | 17 | Legacy NDC, 1 package rows | 20241208_68d4314d-1973-481e-806a-da9f5b4baeb0.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 |
|---|
| 0955-1702-10 | 00955170210 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0955-1702-10) | 2010-10-14 | 0000-00-00 | No | No | Current |