zolpidem tartrate

Generic: zolpidem tartrate

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

Drug Facts

Product Profile

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

zolpidem tartrate 5 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-621
Product ID 16714-621_8d310ac3-c04b-4a08-babe-406d574c5ce3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078413
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2007-05-04

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 16714621
Hyphenated Format 16714-621

Supplemental Identifiers

RxCUI
854873 854876
UPC
0316714621012 0316714622019
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 ANDA078413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16714-621-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16714-621-02)
  • 10 BLISTER PACK in 1 CARTON (16714-621-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (16714-621-10)
source: ndc

Packages (3)

16714-621-01 100 TABLET, FILM COATED in 1 BOTTLE (16714-621-01) 16714-621-02 500 TABLET, FILM COATED in 1 BOTTLE (16714-621-02) 16714-621-11 10 BLISTER PACK in 1 CARTON (16714-621-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (16714-621-10)

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": "8d310ac3-c04b-4a08-babe-406d574c5ce3", "openfda": {"upc": ["0316714621012", "0316714622019"], "unii": ["WY6W63843K"], "rxcui": ["854873", "854876"], "spl_set_id": ["51c9a29c-a285-40d0-bf3a-7e8c944ee39c"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16714-621-01)", "package_ndc": "16714-621-01", "marketing_start_date": "20070504"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16714-621-02)", "package_ndc": "16714-621-02", "marketing_start_date": "20070504"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (16714-621-11)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (16714-621-10)", "package_ndc": "16714-621-11", "marketing_start_date": "20070504"}], "brand_name": "Zolpidem Tartrate", "product_id": "16714-621_8d310ac3-c04b-4a08-babe-406d574c5ce3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "Pyridines [CS]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "16714-621", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA078413", "marketing_category": "ANDA", "marketing_start_date": "20070504", "listing_expiration_date": "20261231"}