modafinil

Generic: modafinil

Labeler: cima labs inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name modafinil
Generic Name modafinil
Labeler cima labs inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

modafinil 100 mg/1

Manufacturer
CIMA LABS INC.

Identifiers & Regulatory

Product NDC 55253-801
Product ID 55253-801_428b6de2-f791-43db-a186-d19312a348fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020717
DEA Schedule civ
Marketing Start 2012-03-29
Marketing End 2027-03-31

Pharmacologic Class

Established (EPC)
sympathomimetic-like agent [epc]
Physiologic Effect
central nervous system stimulation [pe] increased sympathetic activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55253801
Hyphenated Format 55253-801

Supplemental Identifiers

RxCUI
205324 260218
UNII
R3UK8X3U3D
NUI
N0000175729 N0000175651 N0000175769

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 modafinil (source: ndc)
Generic Name modafinil (source: ndc)
Application Number NDA020717 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (55253-801-30)
source: ndc

Packages (1)

55253-801-30 30 TABLET in 1 BOTTLE (55253-801-30)

Ingredients (1)

modafinil (100 mg/1)

Linked Drug Pages (1)

Modafinil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "428b6de2-f791-43db-a186-d19312a348fd", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324", "260218"], "spl_set_id": ["9f3b0bd2-72a3-411f-aeec-b533373f1a97"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["CIMA LABS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (55253-801-30)", "package_ndc": "55253-801-30", "marketing_end_date": "20270331", "marketing_start_date": "20120329"}], "brand_name": "Modafinil", "product_id": "55253-801_428b6de2-f791-43db-a186-d19312a348fd", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "55253-801", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "CIMA LABS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Modafinil", "active_ingredients": [{"name": "MODAFINIL", "strength": "100 mg/1"}], "application_number": "NDA020717", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20270331", "marketing_start_date": "20120329"}