modafinil

Generic: modafinil

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name modafinil
Generic Name modafinil
Labeler alembic pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

modafinil 100 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-385
Product ID 46708-385_975cac47-5a4b-4a5d-a8c5-2aea808f30ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202700
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2017-06-30

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 46708385
Hyphenated Format 46708-385

Supplemental Identifiers

RxCUI
205324 260218
UPC
0346708385309 0346708386306
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 ANDA202700 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 CARTON (46708-385-10)
  • 30 TABLET in 1 BOTTLE (46708-385-30)
  • 60 TABLET in 1 BOTTLE (46708-385-60)
  • 90 TABLET in 1 BOTTLE (46708-385-90)
  • 1000 TABLET in 1 BOTTLE (46708-385-91)
source: ndc

Packages (5)

46708-385-10 100 TABLET in 1 CARTON (46708-385-10) 46708-385-30 30 TABLET in 1 BOTTLE (46708-385-30) 46708-385-60 60 TABLET in 1 BOTTLE (46708-385-60) 46708-385-90 90 TABLET in 1 BOTTLE (46708-385-90) 46708-385-91 1000 TABLET in 1 BOTTLE (46708-385-91)

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": "975cac47-5a4b-4a5d-a8c5-2aea808f30ca", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "upc": ["0346708385309", "0346708386306"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324", "260218"], "spl_set_id": ["5b8496fe-b647-4ce6-aeef-71245712e46f"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 CARTON (46708-385-10)", "package_ndc": "46708-385-10", "marketing_start_date": "20170630"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (46708-385-30)", "package_ndc": "46708-385-30", "marketing_start_date": "20170630"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (46708-385-60)", "package_ndc": "46708-385-60", "marketing_start_date": "20170630"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (46708-385-90)", "package_ndc": "46708-385-90", "marketing_start_date": "20170630"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-385-91)", "package_ndc": "46708-385-91", "marketing_start_date": "20170630"}], "brand_name": "Modafinil", "product_id": "46708-385_975cac47-5a4b-4a5d-a8c5-2aea808f30ca", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "46708-385", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Modafinil", "active_ingredients": [{"name": "MODAFINIL", "strength": "100 mg/1"}], "application_number": "ANDA202700", "marketing_category": "ANDA", "marketing_start_date": "20170630", "listing_expiration_date": "20261231"}