zolpidem tartrate

Generic: zolpidem tartrate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zolpidem tartrate 10 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-160
Product ID 65862-160_20538e7c-367f-4574-a6db-a2aab4bce2ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078413
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2007-05-04

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 65862160
Hyphenated Format 65862-160

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 tartrate (source: ndc)
Generic Name zolpidem tartrate (source: ndc)
Application Number ANDA078413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-160-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-160-05)
  • 10 BLISTER PACK in 1 CARTON (65862-160-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-160-99)
source: ndc

Packages (4)

65862-160-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-160-01) 65862-160-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-160-05) 65862-160-10 10 BLISTER PACK in 1 CARTON (65862-160-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 65862-160-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-160-99)

Ingredients (1)

zolpidem tartrate (10 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": "20538e7c-367f-4574-a6db-a2aab4bce2ba", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873", "854876"], "spl_set_id": ["ea2067bd-1622-4d98-8012-2c09405aa88d"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-160-01)", "package_ndc": "65862-160-01", "marketing_start_date": "20070504"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-160-05)", "package_ndc": "65862-160-05", "marketing_start_date": "20070504"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-160-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-160-10", "marketing_start_date": "20070504"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-160-99)", "package_ndc": "65862-160-99", "marketing_start_date": "20070504"}], "brand_name": "Zolpidem Tartrate", "product_id": "65862-160_20538e7c-367f-4574-a6db-a2aab4bce2ba", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "Pyridines [CS]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "65862-160", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA078413", "marketing_category": "ANDA", "marketing_start_date": "20070504", "listing_expiration_date": "20261231"}