zolpidem

Generic: zolpidem tartrate

Labeler: aci healthcare usa, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem
Generic Name zolpidem tartrate
Labeler aci healthcare usa, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

zolpidem tartrate 5 mg/1

Manufacturer
ACI Healthcare USA, Inc

Identifiers & Regulatory

Product NDC 71093-155
Product ID 71093-155_69a3d187-578f-4e49-b8b3-109219a7bdf6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077214
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2020-09-24

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 71093155
Hyphenated Format 71093-155

Supplemental Identifiers

RxCUI
854873 854876
UNII
WY6W63843K

Packaging Origin

Original Packager
true

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 (source: ndc)
Generic Name zolpidem tartrate (source: ndc)
Application Number ANDA077214 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (71093-155-04)
  • 1000 TABLET in 1 BOTTLE (71093-155-06)
source: ndc

Packages (2)

71093-155-04 100 TABLET in 1 BOTTLE (71093-155-04) 71093-155-06 1000 TABLET in 1 BOTTLE (71093-155-06)

Ingredients (1)

zolpidem tartrate (5 mg/1)

Linked Drug Pages (1)

Zolpidem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "69a3d187-578f-4e49-b8b3-109219a7bdf6", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873", "854876"], "spl_set_id": ["021153ce-fe27-4ed1-8d88-b4157b0ed734"], "manufacturer_name": ["ACI Healthcare USA, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (71093-155-04)", "package_ndc": "71093-155-04", "marketing_start_date": "20200924"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (71093-155-06)", "package_ndc": "71093-155-06", "marketing_start_date": "20200924"}], "brand_name": "Zolpidem", "product_id": "71093-155_69a3d187-578f-4e49-b8b3-109219a7bdf6", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "Pyridines [CS]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "71093-155", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "ACI Healthcare USA, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA077214", "marketing_category": "ANDA", "marketing_start_date": "20200924", "listing_expiration_date": "20261231"}