zolpidem tartrate

Generic: zolpidem tartrate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

zolpidem tartrate 6.25 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-779
Product ID 68180-779_e56668d7-16c2-4618-ba3b-df3853f307e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078970
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2014-04-11

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 68180779
Hyphenated Format 68180-779

Supplemental Identifiers

RxCUI
854880 854894
UPC
0368180779049 0368180780045
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 ANDA078970 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-779-04)
source: ndc

Packages (1)

68180-779-04 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-779-04)

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": "e56668d7-16c2-4618-ba3b-df3853f307e6", "openfda": {"upc": ["0368180779049", "0368180780045"], "unii": ["WY6W63843K"], "rxcui": ["854880", "854894"], "spl_set_id": ["ac647afe-2fe5-4056-806f-abdd54789b45"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-779-04)", "package_ndc": "68180-779-04", "marketing_start_date": "20240521"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "68180-779_e56668d7-16c2-4618-ba3b-df3853f307e6", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "68180-779", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZOLPIDEM TARTRATE", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "6.25 mg/1"}], "application_number": "ANDA078970", "marketing_category": "ANDA", "marketing_start_date": "20140411", "listing_expiration_date": "20261231"}