edluar

Generic: zolpidem tartrate

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name edluar
Generic Name zolpidem tartrate
Labeler viatris specialty llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

zolpidem tartrate 5 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 0037-6050
Product ID 0037-6050_f9d32621-9e2f-4dbf-8189-c5ab3168b5d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021997
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2009-07-24

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 00376050
Hyphenated Format 0037-6050

Supplemental Identifiers

RxCUI
836641 836645 836647 836649
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 edluar (source: ndc)
Generic Name zolpidem tartrate (source: ndc)
Application Number NDA021997 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (0037-6050-93) / 6 TABLET in 1 BLISTER PACK (0037-6050-35)
source: ndc

Packages (1)

0037-6050-93 5 BLISTER PACK in 1 CARTON (0037-6050-93) / 6 TABLET in 1 BLISTER PACK (0037-6050-35)

Ingredients (1)

zolpidem tartrate (5 mg/1)

Linked Drug Pages (1)

Edluar ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f9d32621-9e2f-4dbf-8189-c5ab3168b5d2", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["836641", "836645", "836647", "836649"], "spl_set_id": ["a32884d0-85b5-11de-8a39-0800200c9a66"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (0037-6050-93)  / 6 TABLET in 1 BLISTER PACK (0037-6050-35)", "package_ndc": "0037-6050-93", "marketing_start_date": "20220216"}], "brand_name": "Edluar", "product_id": "0037-6050_f9d32621-9e2f-4dbf-8189-c5ab3168b5d2", "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": "0037-6050", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Edluar", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "NDA021997", "marketing_category": "NDA", "marketing_start_date": "20090724", "listing_expiration_date": "20261231"}