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NDC 68180-0779-03 ZOLPIDEM TARTRATE 6.25 mg/1 Details
ZOLPIDEM TARTRATE 6.25 mg/1
ZOLPIDEM TARTRATE is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin 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: 68180-0779-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Zolpidem
Product Information
NDC | 68180-0779 |
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Product ID | 68180-779_0b0d439e-9812-4697-a98b-023eb50fb972 |
Associated GPIs | 60204080100410 |
GCN Sequence Number | 059696 |
GCN Sequence Number Description | zolpidem tartrate TAB MPHASE 6.25 MG ORAL |
HIC3 | H2E |
HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
GCN | 25456 |
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, EXTENDED RELEASE |
Route | ORAL |
Active Ingredient Strength | 6.25 |
Active Ingredient Units | mg/1 |
Substance Name | ZOLPIDEM TARTRATE |
Labeler Name | Lupin 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 | ANDA078970 |
Listing Certified Through | 2025-12-31 |
Package
NDC 68180-0779-03 (68180077903)
NDC Package Code | 68180-779-03 |
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Billing NDC | 68180077903 |
Package | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-779-03) |
Marketing Start Date | 2014-04-11 |
NDC Exclude Flag | N |
Pricing Information | N/A |