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
Routes
SUBLINGUAL
Active Ingredients

zolpidem tartrate 3.5 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-761
Product ID 43386-761_b4684db4-fae2-5bc4-e053-2995a90a9cd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204299
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2016-03-22

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 43386761
Hyphenated Format 43386-761

Supplemental Identifiers

RxCUI
1232194 1232202
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 ANDA204299 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (43386-761-30) / 1 BLISTER PACK in 1 POUCH (43386-761-01) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

43386-761-30 30 POUCH in 1 CARTON (43386-761-30) / 1 BLISTER PACK in 1 POUCH (43386-761-01) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

zolpidem tartrate (3.5 mg/1)

Linked Drug Pages (1)

ZOLPIDEM TARTRATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "b4684db4-fae2-5bc4-e053-2995a90a9cd1", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["1232194", "1232202"], "spl_set_id": ["6db679f6-b1f8-4fbf-9e87-9cef4650c45a"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (43386-761-30)  / 1 BLISTER PACK in 1 POUCH (43386-761-01)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "43386-761-30", "marketing_start_date": "20160322"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "43386-761_b4684db4-fae2-5bc4-e053-2995a90a9cd1", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "Pyridines [CS]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "43386-761", "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": "3.5 mg/1"}], "application_number": "ANDA204299", "marketing_category": "ANDA", "marketing_start_date": "20160322", "listing_expiration_date": "20261231"}