ZOLPIDEM TARTRATE
- Product NDC
- 72722-103
- 11-digit product format
- 727220103
- Labeler code
- 72722
- Product ID
- 72722-103_745d297b-54a1-4d6f-8f60-44cbbdc0e758
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- The ACME Laboratories Ltd.
- Application
- ANDA077214
- Marketing category
- ANDA
- Marketing start
- 2020-09-24
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 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
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZOLPIDEM TARTRATE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLPIDEM TARTRATE | 5 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 |
|---|
| 72722-103-01 | ZOLPIDEM TARTRATE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 72722-103-05 | ZOLPIDEM TARTRATE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 72722-103-07 | ZOLPIDEM TARTRATE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72722-103 | ZOLPIDEM TARTRATE TABLET, FILM COATED [THE ACME LABORATORIES LTD.] | 1 | Current NDC, 3 package rows | 20241122_5679ed64-8424-4e63-a3c9-91d80fff2ca6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72722-103-01 | 72722010301 | 30 TABLET, FILM COATED in 1 BOTTLE (72722-103-01) | 2024-11-30 | No | No | Historical |
| 72722-103-05 | 72722010305 | 100 TABLET, FILM COATED in 1 BOTTLE (72722-103-05) | 2024-11-30 | No | No | Historical |
| 72722-103-07 | 72722010307 | 1000 TABLET, FILM COATED in 1 BOTTLE (72722-103-07) | 2024-11-30 | No | No | Historical |