zaleplon

Generic: zaleplon

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zaleplon
Generic Name zaleplon
Labeler a-s medication solutions
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zaleplon 10 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-1564
Product ID 50090-1564_b6f10404-69b2-47b0-970e-bf392d4a6ebd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078989
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2009-05-05

Pharmacologic Class

Established (EPC)
gamma-aminobutyric acid a receptor agonist [epc]
Mechanism of Action
gaba a agonists [moa]
Physiologic Effect
central nervous system depression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500901564
Hyphenated Format 50090-1564

Supplemental Identifiers

RxCUI
313761
UNII
S62U433RMH
NUI
N0000183360 N0000000196 N0000175728

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 zaleplon (source: ndc)
Generic Name zaleplon (source: ndc)
Application Number ANDA078989 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE (50090-1564-0)
  • 30 CAPSULE in 1 BOTTLE (50090-1564-1)
source: ndc

Packages (2)

50090-1564-0 10 CAPSULE in 1 BOTTLE (50090-1564-0) 50090-1564-1 30 CAPSULE in 1 BOTTLE (50090-1564-1)

Ingredients (1)

zaleplon (10 mg/1)

Linked Drug Pages (1)

zaleplon ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b6f10404-69b2-47b0-970e-bf392d4a6ebd", "openfda": {"nui": ["N0000183360", "N0000000196", "N0000175728"], "unii": ["S62U433RMH"], "rxcui": ["313761"], "spl_set_id": ["8276a418-6a4c-4b81-8170-2d3838576c6d"], "pharm_class_pe": ["Central Nervous System Depression [PE]"], "pharm_class_epc": ["gamma-Aminobutyric Acid A Receptor Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE (50090-1564-0)", "package_ndc": "50090-1564-0", "marketing_start_date": "20141222"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (50090-1564-1)", "package_ndc": "50090-1564-1", "marketing_start_date": "20141222"}], "brand_name": "zaleplon", "product_id": "50090-1564_b6f10404-69b2-47b0-970e-bf392d4a6ebd", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "gamma-Aminobutyric Acid A Receptor Agonist [EPC]"], "product_ndc": "50090-1564", "dea_schedule": "CIV", "generic_name": "zaleplon", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "zaleplon", "active_ingredients": [{"name": "ZALEPLON", "strength": "10 mg/1"}], "application_number": "ANDA078989", "marketing_category": "ANDA", "marketing_start_date": "20090505", "listing_expiration_date": "20261231"}