Zolpidem Tartrate
- Product NDC
- 72789-323
- 11-digit product format
- 727890323
- Labeler code
- 72789
- Product ID
- 72789-323_2c50fde4-3d33-4137-e063-6394a90a73d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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 Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-323-01 | Zolpidem Tartrate | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 30 |
| 72789-323-10 | Zolpidem Tartrate | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 30 |
| 72789-323-14 | Zolpidem Tartrate | 14 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 14 | | 30 |
| 72789-323-15 | Zolpidem Tartrate | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 30 |
| 72789-323-21 | Zolpidem Tartrate | 21 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 21 | | 30 |
| 72789-323-30 | Zolpidem Tartrate | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 30 |
| 72789-323-60 | Zolpidem Tartrate | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 30 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-323 | ZOLPIDEM TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 30 | Current NDC, 7 package rows | 20250124_fda413e7-b1ae-312a-e053-6394a90ab2c6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-323-01 | 72789032301 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-01) | 2007-05-04 | No | No | Current |
| 72789-323-10 | 72789032310 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-10) | 2023-10-30 | No | No | Current |
| 72789-323-14 | 72789032314 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-14) | 2024-01-10 | No | No | Current |
| 72789-323-15 | 72789032315 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-15) | 2023-09-25 | No | No | Current |
| 72789-323-21 | 72789032321 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-21) | 2023-11-09 | No | No | Current |
| 72789-323-30 | 72789032330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-30) | 2007-05-04 | No | No | Current |
| 72789-323-60 | 72789032360 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-60) | 2007-05-04 | No | No | Current |