zaleplon

Generic: zaleplon

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zaleplon
Generic Name zaleplon
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zaleplon 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-783
Product ID 43063-783_414baf08-dc02-c431-e063-6394a90ae4ee
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 43063783
Hyphenated Format 43063-783

Supplemental Identifiers

RxCUI
313761
UPC
0343063783108
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, PLASTIC (43063-783-10)
source: ndc

Packages (1)

43063-783-10 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-783-10)

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": "414baf08-dc02-c431-e063-6394a90ae4ee", "openfda": {"nui": ["N0000183360", "N0000000196", "N0000175728"], "upc": ["0343063783108"], "unii": ["S62U433RMH"], "rxcui": ["313761"], "spl_set_id": ["2cc7adee-2c4c-4fed-9914-545e70dba773"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE, PLASTIC (43063-783-10)", "package_ndc": "43063-783-10", "marketing_start_date": "20170824"}], "brand_name": "zaleplon", "product_id": "43063-783_414baf08-dc02-c431-e063-6394a90ae4ee", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "gamma-Aminobutyric Acid A Receptor Agonist [EPC]"], "product_ndc": "43063-783", "dea_schedule": "CIV", "generic_name": "zaleplon", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}