zaleplon

Generic: zaleplon

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zaleplon
Generic Name zaleplon
Labeler hikma pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zaleplon 10 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0085
Product ID 0054-0085_d97e7e61-defc-47f5-aeca-11cecae47e79
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077237
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2008-06-06

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 00540085
Hyphenated Format 0054-0085

Supplemental Identifiers

RxCUI
313761 313762
UPC
0300540085254 0300540084257
UNII
S62U433RMH
NUI
N0000183360 N0000000196 N0000175728

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 zaleplon (source: ndc)
Generic Name zaleplon (source: ndc)
Application Number ANDA077237 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0054-0085-25)
source: ndc

Packages (1)

0054-0085-25 100 CAPSULE in 1 BOTTLE (0054-0085-25)

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": "d97e7e61-defc-47f5-aeca-11cecae47e79", "openfda": {"nui": ["N0000183360", "N0000000196", "N0000175728"], "upc": ["0300540085254", "0300540084257"], "unii": ["S62U433RMH"], "rxcui": ["313761", "313762"], "spl_set_id": ["cadd9d75-2139-4fab-94ce-2992e6a55780"], "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": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0054-0085-25)", "package_ndc": "0054-0085-25", "marketing_start_date": "20080606"}], "brand_name": "Zaleplon", "product_id": "0054-0085_d97e7e61-defc-47f5-aeca-11cecae47e79", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "gamma-Aminobutyric Acid A Receptor Agonist [EPC]"], "product_ndc": "0054-0085", "dea_schedule": "CIV", "generic_name": "Zaleplon", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zaleplon", "active_ingredients": [{"name": "ZALEPLON", "strength": "10 mg/1"}], "application_number": "ANDA077237", "marketing_category": "ANDA", "marketing_start_date": "20080606", "listing_expiration_date": "20261231"}