Zolpidem Tartrate
- Product NDC
- 16714-622
- 11-digit product format
- 167140622
- Labeler code
- 16714
- Product ID
- 16714-622_8d310ac3-c04b-4a08-babe-406d574c5ce3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA078413
- Marketing category
- ANDA
- Marketing start
- 2007-05-04
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 10 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zolpidem Tartrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLPIDEM TARTRATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 854873, 854876 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-622-01 | Zolpidem Tartrate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 16 |
| 16714-622-02 | Zolpidem Tartrate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 16 |
| 16714-622-10 | Zolpidem Tartrate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 16 |
| 16714-622-11 | Zolpidem Tartrate | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 16 |
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 [NORTHSTAR RX LLC] | 5 | |
| ZOLPIDEM | ACTIVE MOIETY | 7K383OQI23 | ZOLPIDEM TARTRATE TABLET, FILM COATED [NORTHSTAR RX LLC] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZOLPIDEM TARTRATE TABLET, FILM COATED [NORTHSTAR RX LLC] | 5 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | ZOLPIDEM TARTRATE TABLET, FILM COATED [NORTHSTAR RX LLC] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ZOLPIDEM TARTRATE TABLET, FILM COATED [NORTHSTAR RX LLC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZOLPIDEM TARTRATE TABLET, FILM COATED [NORTHSTAR RX LLC] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ZOLPIDEM TARTRATE TABLET, FILM COATED [NORTHSTAR RX LLC] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ZOLPIDEM TARTRATE TABLET, FILM COATED [NORTHSTAR RX LLC] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZOLPIDEM TARTRATE TABLET, FILM COATED [NORTHSTAR RX LLC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-622 | ZOLPIDEM TARTRATE TABLET, FILM COATED [NORTHSTAR RX LLC] | 16 | Current NDC, Legacy NDC, 4 package rows | 20240201_51c9a29c-a285-40d0-bf3a-7e8c944ee39c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-622-01 | 16714062201 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-622-01) | | 2007-05-04 | 0000-00-00 | No | No | Current |
| 16714-622-02 | 16714062202 | 500 TABLET, FILM COATED in 1 BOTTLE (16714-622-02) | | 2007-05-04 | 0000-00-00 | No | No | Current |
| 16714-622-10 | 16714062210 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 16714-622-11 | 16714062211 | 10 BLISTER PACK in 1 CARTON (16714-622-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (16714-622-10) | 10 blister pack | 2007-05-04 | 0000-00-00 | No | No | Current |