zolpidem tartrate

Generic: zolpidem tartrate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 6.25 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-307
Product ID 47335-307_4a5c474b-e752-4d01-be37-a66e7c9bf62e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204170
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2017-05-15

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 47335307
Hyphenated Format 47335-307

Supplemental Identifiers

RxCUI
854880 854894
UPC
0347335307887 0347335308884
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 ANDA204170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-13)
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-88)
source: ndc

Packages (2)

47335-307-13 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-13) 47335-307-88 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-88)

Ingredients (1)

zolpidem tartrate (6.25 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": "4a5c474b-e752-4d01-be37-a66e7c9bf62e", "openfda": {"upc": ["0347335307887", "0347335308884"], "unii": ["WY6W63843K"], "rxcui": ["854880", "854894"], "spl_set_id": ["0c64bc71-2e7f-4b15-a8e1-acb8de04395f"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-13)", "package_ndc": "47335-307-13", "marketing_start_date": "20170515"}, {"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-88)", "package_ndc": "47335-307-88", "marketing_start_date": "20170515"}], "brand_name": "Zolpidem Tartrate", "product_id": "47335-307_4a5c474b-e752-4d01-be37-a66e7c9bf62e", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "Pyridines [CS]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "47335-307", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "6.25 mg/1"}], "application_number": "ANDA204170", "marketing_category": "ANDA", "marketing_start_date": "20170515", "listing_expiration_date": "20261231"}