zolpidem tartrate

Generic: zolpidem tartrate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler proficient rx lp
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 12.5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-286
Product ID 71205-286_bde02c60-5382-4505-b806-ddb2f5f9deab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078970
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2014-04-11

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 71205286
Hyphenated Format 71205-286

Supplemental Identifiers

RxCUI
854880
UPC
0371205286309
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 ANDA078970 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-90)
source: ndc

Packages (3)

71205-286-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-30) 71205-286-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-60) 71205-286-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-90)

Ingredients (1)

zolpidem tartrate (12.5 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": "bde02c60-5382-4505-b806-ddb2f5f9deab", "openfda": {"upc": ["0371205286309"], "unii": ["WY6W63843K"], "rxcui": ["854880"], "spl_set_id": ["acf9f431-3013-4cfd-ba4d-c4013f20bdab"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-30)", "package_ndc": "71205-286-30", "marketing_start_date": "20190621"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-60)", "package_ndc": "71205-286-60", "marketing_start_date": "20190621"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-90)", "package_ndc": "71205-286-90", "marketing_start_date": "20190621"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "71205-286_bde02c60-5382-4505-b806-ddb2f5f9deab", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "Pyridines [CS]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "71205-286", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZOLPIDEM TARTRATE", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "12.5 mg/1"}], "application_number": "ANDA078970", "marketing_category": "ANDA", "marketing_start_date": "20140411", "listing_expiration_date": "20261231"}