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NDC 53002-1292-02 ZOLPIDEM TARTRATE 5 mg/1 Details
ZOLPIDEM TARTRATE 5 mg/1
ZOLPIDEM TARTRATE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is ZOLPIDEM TARTRATE.
MedlinePlus Drug Summary
Zolpidem is used to treat insomnia (difficulty falling asleep or staying asleep). Zolpidem belongs to a class of medications called sedative-hypnotics. It works by slowing activity in the brain to allow sleep.
Related Packages: 53002-1292-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Zolpidem
Product Information
| NDC | 53002-1292 |
|---|---|
| Product ID | 53002-1292_51c9f718-3736-4985-9729-0510e6a222a6 |
| Associated GPIs | 60204080100310 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | ZOLPIDEM TARTRATE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | zolpidem tartrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | ZOLPIDEM TARTRATE |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Pharmaceutical Class | Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA077903 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53002-1292-02 (53002129202)
| NDC Package Code | 53002-1292-2 |
|---|---|
| Billing NDC | 53002129202 |
| Package | 20 TABLET in 1 BOTTLE (53002-1292-2) |
| Marketing Start Date | 2017-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |