zolpidem tartrate sublingual

Generic: zolpidem tartrate sublingual

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate sublingual
Generic Name zolpidem tartrate sublingual
Labeler endo usa, inc.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

zolpidem tartrate 1.75 mg/1

Manufacturer
ENDO USA, Inc.

Identifiers & Regulatory

Product NDC 49884-898
Product ID 49884-898_d2373932-da6e-4cf7-857d-46899fda3063
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204229
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2017-09-11

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 49884898
Hyphenated Format 49884-898

Supplemental Identifiers

RxCUI
1232194 1232202
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 sublingual (source: ndc)
Generic Name zolpidem tartrate sublingual (source: ndc)
Application Number ANDA204229 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 1.75 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (49884-898-11) / 1 TABLET in 1 POUCH (49884-898-52)
source: ndc

Packages (1)

49884-898-11 30 POUCH in 1 CARTON (49884-898-11) / 1 TABLET in 1 POUCH (49884-898-52)

Ingredients (1)

zolpidem tartrate (1.75 mg/1)

Linked Drug Pages (1)

Zolpidem tartrate sublingual ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "d2373932-da6e-4cf7-857d-46899fda3063", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["1232194", "1232202"], "spl_set_id": ["44b34e58-114b-4774-9fab-4b188dfe0228"], "manufacturer_name": ["ENDO USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (49884-898-11)  / 1 TABLET in 1 POUCH (49884-898-52)", "package_ndc": "49884-898-11", "marketing_start_date": "20170911"}], "brand_name": "Zolpidem tartrate sublingual", "product_id": "49884-898_d2373932-da6e-4cf7-857d-46899fda3063", "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": "49884-898", "dea_schedule": "CIV", "generic_name": "Zolpidem tartrate sublingual", "labeler_name": "ENDO USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem tartrate sublingual", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "1.75 mg/1"}], "application_number": "ANDA204229", "marketing_category": "ANDA", "marketing_start_date": "20170911", "listing_expiration_date": "20261231"}