ZOLPIDEM TARTRATE
- Product NDC
- 52959-879
- 11-digit product format
- 529590879
- Labeler code
- 52959
- Product ID
- 52959-879_69700973-a736-2ff3-e053-2991aa0a12d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ZOLPIDEM TARTRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- H. J. Harkins Co., Inc.
- Application
- ANDA077903
- Marketing category
- ANDA
- Marketing start
- 2017-11-16
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 52959-879-30 | Gabazolpidem-5 | 30 in 1 BOTTLE | TABLET | 30 | 5 mg | 7 |
| 52959-879-30 | Sentrazolpidem PM-5 | 30 in 1 BOTTLE | TABLET | 30 | 5 mg | 6 |
| 52959-879-00 | ZOLPIDEM TARTRATE | 100 in 1 CONTAINER | TABLET | 100 | | 1 |
| 52959-879-10 | ZOLPIDEM TARTRATE | 10 in 1 BOTTLE | TABLET | 10 | | 1 |
| 52959-879-15 | ZOLPIDEM TARTRATE | 15 in 1 BOTTLE | TABLET | 15 | | 1 |
| 52959-879-20 | ZOLPIDEM TARTRATE | 20 in 1 BOTTLE | TABLET | 20 | | 1 |
| 52959-879-30 | ZOLPIDEM TARTRATE | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 52959-879-60 | ZOLPIDEM TARTRATE | 60 in 1 CONTAINER | TABLET | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CHOLINE | ACTIVE INGREDIENT | N91BDP6H0X | GABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| ZOLPIDEM TARTRATE | ACTIVE INGREDIENT | WY6W63843K | GABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| CHOLINE | ACTIVE MOIETY | N91BDP6H0X | GABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| ZOLPIDEM | ACTIVE MOIETY | 7K383OQI23 | GABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | GABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | GABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| CHOLINE | ACTIVE INGREDIENT | N91BDP6H0X | SENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 6 | |
| ZOLPIDEM TARTRATE | ACTIVE INGREDIENT | WY6W63843K | SENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 6 | |
| CHOLINE | ACTIVE MOIETY | N91BDP6H0X | SENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 6 | |
| ZOLPIDEM | ACTIVE MOIETY | 7K383OQI23 | SENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 6 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | SENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 6 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | SENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-879 | GABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | Legacy NDC | 20110815_d31076b4-44ac-4f8b-8df6-5200cdbea12b.zip |
| 52959-879 | SENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 6 | Legacy NDC | 20110815_54101870-d8a8-4b35-a31d-93480af9d181.zip |
| 52959-879 | ZOLPIDEM TARTRATE TABLET [H. J. HARKINS CO., INC.] | 1 | Legacy NDC, 1 package rows | 20180410_69700973-a735-2ff3-e053-2991aa0a12d1.zip |
| 52959-879 | ZOLPIDEM TARTRATE TABLET [H.J HARKINS COMPANY INC.] | 1 | Legacy NDC, 5 package rows | 20171108_5d59fb92-77d6-bcd0-e053-2991aa0ac409.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-879-00 | 52959087900 | 100 in 1 CONTAINER | Historical |
| 52959-879-10 | 52959087910 | 10 in 1 BOTTLE | Historical |
| 52959-879-15 | 52959087915 | 15 in 1 BOTTLE | Historical |
| 52959-879-20 | 52959087920 | 20 in 1 BOTTLE | Historical |
| 52959-879-30 | 52959087930 | 30 in 1 BOTTLE | Historical |
| 52959-879-60 | 52959087960 | 60 in 1 CONTAINER | Historical |