zaleplon

Generic: zaleplon

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

Drug Facts

Product Profile

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

zaleplon 10 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8725
Product ID 68788-8725_c90005da-3a75-4408-b34d-22f2394bf01f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090374
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-08-16

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 687888725
Hyphenated Format 68788-8725

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 ANDA090374 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68788-8725-1)
  • 20 CAPSULE in 1 BOTTLE (68788-8725-2)
  • 30 CAPSULE in 1 BOTTLE (68788-8725-3)
  • 60 CAPSULE in 1 BOTTLE (68788-8725-6)
  • 90 CAPSULE in 1 BOTTLE (68788-8725-9)
source: ndc

Packages (5)

68788-8725-1 100 CAPSULE in 1 BOTTLE (68788-8725-1) 68788-8725-2 20 CAPSULE in 1 BOTTLE (68788-8725-2) 68788-8725-3 30 CAPSULE in 1 BOTTLE (68788-8725-3) 68788-8725-6 60 CAPSULE in 1 BOTTLE (68788-8725-6) 68788-8725-9 90 CAPSULE in 1 BOTTLE (68788-8725-9)

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": "c90005da-3a75-4408-b34d-22f2394bf01f", "openfda": {"nui": ["N0000183360", "N0000000196", "N0000175728"], "unii": ["S62U433RMH"], "rxcui": ["313761"], "spl_set_id": ["d58138d1-3378-482c-a401-958dabe1be7d"], "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": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68788-8725-1)", "package_ndc": "68788-8725-1", "marketing_start_date": "20240816"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (68788-8725-2)", "package_ndc": "68788-8725-2", "marketing_start_date": "20240816"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8725-3)", "package_ndc": "68788-8725-3", "marketing_start_date": "20240816"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68788-8725-6)", "package_ndc": "68788-8725-6", "marketing_start_date": "20240816"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68788-8725-9)", "package_ndc": "68788-8725-9", "marketing_start_date": "20240816"}], "brand_name": "Zaleplon", "product_id": "68788-8725_c90005da-3a75-4408-b34d-22f2394bf01f", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "gamma-Aminobutyric Acid A Receptor Agonist [EPC]"], "product_ndc": "68788-8725", "dea_schedule": "CIV", "generic_name": "Zaleplon", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zaleplon", "active_ingredients": [{"name": "ZALEPLON", "strength": "10 mg/1"}], "application_number": "ANDA090374", "marketing_category": "ANDA", "marketing_start_date": "20240816", "listing_expiration_date": "20261231"}