zolpidem tartrate

Generic: zolpidem tartrate

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler torrent pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

zolpidem tartrate 5 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-007
Product ID 13668-007_783b6c2c-bec3-44db-b758-d762377a34ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077903
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2007-09-05

Pharmacologic Class

Classes
central nervous system depression [pe] gaba a receptor positive modulators [moa] gamma-aminobutyric acid a receptor positive modulator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668007
Hyphenated Format 13668-007

Supplemental Identifiers

RxCUI
854873 854876
UPC
0313668008302 0313668007305
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 ANDA077903 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13668-007-01)
  • 500 TABLET in 1 BOTTLE (13668-007-05)
  • 1000 TABLET in 1 BOTTLE (13668-007-10)
  • 1500 TABLET in 1 BOTTLE (13668-007-15)
  • 30 TABLET in 1 BOTTLE (13668-007-30)
  • 90 TABLET in 1 BOTTLE (13668-007-90)
source: ndc

Packages (6)

13668-007-01 100 TABLET in 1 BOTTLE (13668-007-01) 13668-007-05 500 TABLET in 1 BOTTLE (13668-007-05) 13668-007-10 1000 TABLET in 1 BOTTLE (13668-007-10) 13668-007-15 1500 TABLET in 1 BOTTLE (13668-007-15) 13668-007-30 30 TABLET in 1 BOTTLE (13668-007-30) 13668-007-90 90 TABLET in 1 BOTTLE (13668-007-90)

Ingredients (1)

zolpidem tartrate (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": "783b6c2c-bec3-44db-b758-d762377a34ba", "openfda": {"upc": ["0313668008302", "0313668007305"], "unii": ["WY6W63843K"], "rxcui": ["854873", "854876"], "spl_set_id": ["1584bad1-7bf4-4805-bdd9-7eb0fac92721"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13668-007-01)", "package_ndc": "13668-007-01", "marketing_start_date": "20070905"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (13668-007-05)", "package_ndc": "13668-007-05", "marketing_start_date": "20070905"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13668-007-10)", "package_ndc": "13668-007-10", "marketing_start_date": "20070905"}, {"sample": false, "description": "1500 TABLET in 1 BOTTLE (13668-007-15)", "package_ndc": "13668-007-15", "marketing_start_date": "20070905"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13668-007-30)", "package_ndc": "13668-007-30", "marketing_start_date": "20070905"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (13668-007-90)", "package_ndc": "13668-007-90", "marketing_start_date": "20070905"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "13668-007_783b6c2c-bec3-44db-b758-d762377a34ba", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "13668-007", "dea_schedule": "CIV", "generic_name": "zolpidem tartrate", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZOLPIDEM TARTRATE", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA077903", "marketing_category": "ANDA", "marketing_start_date": "20070905", "listing_expiration_date": "20261231"}