zaleplon

Generic: zaleplon

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zaleplon
Generic Name zaleplon
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zaleplon 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-3405
Product ID 63629-3405_b59bfb24-a009-4400-9ba3-c3d8fd08b36a
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 636293405
Hyphenated Format 63629-3405

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
  • 15 CAPSULE in 1 BOTTLE (63629-3405-1)
  • 30 CAPSULE in 1 BOTTLE (63629-3405-2)
  • 60 CAPSULE in 1 BOTTLE (63629-3405-3)
  • 90 CAPSULE in 1 BOTTLE (63629-3405-4)
source: ndc

Packages (4)

63629-3405-1 15 CAPSULE in 1 BOTTLE (63629-3405-1) 63629-3405-2 30 CAPSULE in 1 BOTTLE (63629-3405-2) 63629-3405-3 60 CAPSULE in 1 BOTTLE (63629-3405-3) 63629-3405-4 90 CAPSULE in 1 BOTTLE (63629-3405-4)

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": "b59bfb24-a009-4400-9ba3-c3d8fd08b36a", "openfda": {"nui": ["N0000183360", "N0000000196", "N0000175728"], "unii": ["S62U433RMH"], "rxcui": ["313761"], "spl_set_id": ["b8032b14-5068-19d5-e063-839ed25d7200"], "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": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "15 CAPSULE in 1 BOTTLE (63629-3405-1)", "package_ndc": "63629-3405-1", "marketing_start_date": "20211222"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (63629-3405-2)", "package_ndc": "63629-3405-2", "marketing_start_date": "20211222"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (63629-3405-3)", "package_ndc": "63629-3405-3", "marketing_start_date": "20100526"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (63629-3405-4)", "package_ndc": "63629-3405-4", "marketing_start_date": "20130531"}], "brand_name": "zaleplon", "product_id": "63629-3405_b59bfb24-a009-4400-9ba3-c3d8fd08b36a", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "gamma-Aminobutyric Acid A Receptor Agonist [EPC]"], "product_ndc": "63629-3405", "dea_schedule": "CIV", "generic_name": "zaleplon", "labeler_name": "Bryant Ranch Prepack", "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"}