zolpidem tartrate

Generic: zolpidem tartrate

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

zolpidem tartrate 5 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 61919-751
Product ID 61919-751_47e15e5f-bc12-84ec-e063-6394a90a4bf0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077903
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2019-08-19

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 61919751
Hyphenated Format 61919-751

Supplemental Identifiers

RxCUI
854876
UNII
WY6W63843K

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
  • 10 TABLET in 1 BOTTLE (61919-751-10)
  • 20 TABLET in 1 BOTTLE (61919-751-20)
source: ndc

Packages (2)

61919-751-10 10 TABLET in 1 BOTTLE (61919-751-10) 61919-751-20 20 TABLET in 1 BOTTLE (61919-751-20)

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": "47e15e5f-bc12-84ec-e063-6394a90a4bf0", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854876"], "spl_set_id": ["907c7b18-2638-512c-e053-2995a90ae6fd"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (61919-751-10)", "package_ndc": "61919-751-10", "marketing_start_date": "20190819"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (61919-751-20)", "package_ndc": "61919-751-20", "marketing_start_date": "20190819"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "61919-751_47e15e5f-bc12-84ec-e063-6394a90a4bf0", "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": "61919-751", "dea_schedule": "CIV", "generic_name": "ZOLPIDEM TARTRATE", "labeler_name": "Direct_Rx", "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": "20190819", "listing_expiration_date": "20271231"}