zolpidem tartrate

Generic: zolpidem tartrate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zolpidem tartrate 10 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3943
Product ID 70518-3943_3bb20a3a-6c53-a5bd-e063-6394a90a86c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078413
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-12-08

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 705183943
Hyphenated Format 70518-3943

Supplemental Identifiers

RxCUI
854873
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 ANDA078413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3943-0)
source: ndc

Packages (1)

70518-3943-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3943-0)

Ingredients (1)

zolpidem tartrate (10 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": "3bb20a3a-6c53-a5bd-e063-6394a90a86c2", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873"], "spl_set_id": ["cf3dcbde-b92a-4802-98e4-14f00abdf99e"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3943-0)", "package_ndc": "70518-3943-0", "marketing_start_date": "20231208"}], "brand_name": "Zolpidem Tartrate", "product_id": "70518-3943_3bb20a3a-6c53-a5bd-e063-6394a90a86c2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "70518-3943", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA078413", "marketing_category": "ANDA", "marketing_start_date": "20231208", "listing_expiration_date": "20261231"}