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NDC 42291-0963-10 Zolpidem Tartrate 5 mg/1 Details
Zolpidem Tartrate 5 mg/1
Zolpidem Tartrate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. 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: 42291-0963-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Zolpidem
Product Information
| NDC | 42291-0963 |
|---|---|
| Product ID | 42291-963_0e9ae0bc-3da7-cea2-e063-6294a90afff2 |
| Associated GPIs | 60204080100310 |
| GCN Sequence Number | 019187 |
| GCN Sequence Number Description | zolpidem tartrate TABLET 5 MG ORAL |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 00870 |
| HICL Sequence Number | 007842 |
| HICL Sequence Number Description | ZOLPIDEM TARTRATE |
| Brand/Generic | Generic |
| Proprietary Name | Zolpidem Tartrate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zolpidem Tartrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | ZOLPIDEM TARTRATE |
| Labeler Name | AvKARE |
| 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 | ANDA076410 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 42291-0963-10 (42291096310)
| NDC Package Code | 42291-963-10 |
|---|---|
| Billing NDC | 42291096310 |
| Package | 1000 TABLET, FILM COATED in 1 BOTTLE (42291-963-10) |
| Marketing Start Date | 2019-02-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |