zolpidem tartrate

Generic: zolpidem tartrate

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 12.5 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-2354
Product ID 68071-2354_4b3272fa-6308-bed3-e063-6394a90ac433
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078970
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2014-04-11

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 680712354
Hyphenated Format 68071-2354

Supplemental Identifiers

RxCUI
854880
UPC
0368071235494
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
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2354-9)
source: ndc

Packages (1)

68071-2354-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2354-9)

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": "4b3272fa-6308-bed3-e063-6394a90ac433", "openfda": {"upc": ["0368071235494"], "unii": ["WY6W63843K"], "rxcui": ["854880"], "spl_set_id": ["bca751bb-5161-5a95-e053-2a95a90aa2dd"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2354-9)", "package_ndc": "68071-2354-9", "marketing_start_date": "20210303"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "68071-2354_4b3272fa-6308-bed3-e063-6394a90ac433", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "68071-2354", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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": "20271231"}