zolpidem tartrate

Generic: zolpidem tartrate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler asclemed usa, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 12.5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-496
Product ID 76420-496_ea435212-caf8-164b-e053-2a95a90a0bf6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213592
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2020-12-17

Pharmacologic Class

Classes
central nervous system depression [pe] gaba a agonists [moa] pyridines [cs] gamma-aminobutyric acid-ergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420496
Hyphenated Format 76420-496

Supplemental Identifiers

RxCUI
854880 854894
UNII
WY6W63843K

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zolpidem tartrate (source: ndc)
Generic Name zolpidem tartrate (source: ndc)
Application Number ANDA213592 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-01)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-90)
source: ndc

Packages (4)

76420-496-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-01) 76420-496-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-30) 76420-496-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-60) 76420-496-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-90)

Ingredients (1)

zolpidem tartrate (12.5 mg/1)

Linked Drug Pages (1)

Zolpidem Tartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ea435212-caf8-164b-e053-2a95a90a0bf6", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854880", "854894"], "spl_set_id": ["35f6c1ab-a61c-4625-b932-11a7483f1d84"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-01)", "package_ndc": "76420-496-01", "marketing_start_date": "20221005"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-30)", "package_ndc": "76420-496-30", "marketing_start_date": "20221005"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-60)", "package_ndc": "76420-496-60", "marketing_start_date": "20221005"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-90)", "package_ndc": "76420-496-90", "marketing_start_date": "20221005"}], "brand_name": "Zolpidem Tartrate", "product_id": "76420-496_ea435212-caf8-164b-e053-2a95a90a0bf6", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "Pyridines [CS]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "76420-496", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "12.5 mg/1"}], "application_number": "ANDA213592", "marketing_category": "ANDA", "marketing_start_date": "20201217", "listing_expiration_date": "20261231"}