zolpidem tartrate

Generic: zolpidem tartrate

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

zolpidem tartrate 5 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-778
Product ID 62135-778_20bed8c1-035d-7321-e063-6294a90a6e4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077388
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-08-27

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 62135778
Hyphenated Format 62135-778

Supplemental Identifiers

RxCUI
854873 854876
UPC
0362135779900 0362135778903
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 ANDA077388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (62135-778-90)
source: ndc

Packages (1)

62135-778-90 90 TABLET in 1 BOTTLE (62135-778-90)

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": "20bed8c1-035d-7321-e063-6294a90a6e4b", "openfda": {"upc": ["0362135779900", "0362135778903"], "unii": ["WY6W63843K"], "rxcui": ["854873", "854876"], "spl_set_id": ["0dd113e1-f789-48d2-8cb2-d39b71273658"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-778-90)", "package_ndc": "62135-778-90", "marketing_start_date": "20240827"}], "brand_name": "Zolpidem Tartrate", "product_id": "62135-778_20bed8c1-035d-7321-e063-6294a90a6e4b", "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": "62135-778", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA077388", "marketing_category": "ANDA", "marketing_start_date": "20240827", "listing_expiration_date": "20261231"}