Zolpidem Tartrate
- Product NDC
- 0955-1703
- 11-digit product format
- 009551703
- Labeler code
- 0955
- Product ID
- 0955-1703_0e50b7b1-a680-4009-a8d5-d132b5071499
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sanofi-Aventis U.S. LLC
- Application
- NDA021774
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2010-12-06
- Marketing end
- 2026-05-31
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Current FDA listing
- Yes
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 |
|---|
| 0955-1703-10 | 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 | |
| ZOLPIDEM TARTRATE | ACTIVE INGREDIENT | WY6W63843K | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ZOLPIDEM | ACTIVE MOIETY | 7K383OQI23 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POTASSIUM BITARTRATE | INACTIVE INGREDIENT | NPT6P8P3UU | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0955-1703 | ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [SANOFI-AVENTIS U.S. LLC] | 17 | Current NDC, 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 |
|---|
| 0955-1703-10 | 00955170310 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0955-1703-10) | 2010-12-06 | 2026-05-31 | No | No | Current |