zolpidem tartrate

Generic: zolpidem tartrate

Labeler: almatica pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler almatica pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zolpidem tartrate 7.5 mg/1

Manufacturer
Almatica Pharma LLC

Identifiers & Regulatory

Product NDC 52427-775
Product ID 52427-775_1de7823f-3d49-f5ef-f98b-6d34d2419dae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215721
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-05-09

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 52427775
Hyphenated Format 52427-775

Supplemental Identifiers

RxCUI
2637353
UPC
0352427775307
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 NDA215721 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (52427-775-30)
source: ndc

Packages (1)

52427-775-30 30 CAPSULE in 1 BOTTLE (52427-775-30)

Ingredients (1)

zolpidem tartrate (7.5 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": "1de7823f-3d49-f5ef-f98b-6d34d2419dae", "openfda": {"upc": ["0352427775307"], "unii": ["WY6W63843K"], "rxcui": ["2637353"], "spl_set_id": ["2f1a3600-9bd6-3651-3ab5-1e4e0b0a3916"], "manufacturer_name": ["Almatica Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (52427-775-30)", "package_ndc": "52427-775-30", "marketing_start_date": "20230524"}], "brand_name": "zolpidem tartrate", "product_id": "52427-775_1de7823f-3d49-f5ef-f98b-6d34d2419dae", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "52427-775", "dea_schedule": "CIV", "generic_name": "zolpidem tartrate", "labeler_name": "Almatica Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "zolpidem tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "7.5 mg/1"}], "application_number": "NDA215721", "marketing_category": "NDA", "marketing_start_date": "20230509", "listing_expiration_date": "20261231"}