armodafinil

Generic: armodafinil

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

Drug Facts

Product Profile

Brand Name armodafinil
Generic Name armodafinil
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

armodafinil 150 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3432
Product ID 0378-3432_34fcca9f-37ba-40d9-9032-6ffeeb031a36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200043
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2016-06-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03783432
Hyphenated Format 0378-3432

Supplemental Identifiers

RxCUI
724859 724861 724863
UPC
0303783433936 0303783431932 0303783432939
UNII
V63XWA605I

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 armodafinil (source: ndc)
Generic Name armodafinil (source: ndc)
Application Number ANDA200043 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (0378-3432-93)
source: ndc

Packages (1)

0378-3432-93 30 TABLET in 1 BOTTLE, PLASTIC (0378-3432-93)

Ingredients (1)

armodafinil (150 mg/1)

Linked Drug Pages (1)

Armodafinil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "34fcca9f-37ba-40d9-9032-6ffeeb031a36", "openfda": {"upc": ["0303783433936", "0303783431932", "0303783432939"], "unii": ["V63XWA605I"], "rxcui": ["724859", "724861", "724863"], "spl_set_id": ["de0799f7-7644-4057-a7da-75436f978c61"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (0378-3432-93)", "package_ndc": "0378-3432-93", "marketing_start_date": "20160601"}], "brand_name": "Armodafinil", "product_id": "0378-3432_34fcca9f-37ba-40d9-9032-6ffeeb031a36", "dosage_form": "TABLET", "product_ndc": "0378-3432", "dea_schedule": "CIV", "generic_name": "armodafinil", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Armodafinil", "active_ingredients": [{"name": "ARMODAFINIL", "strength": "150 mg/1"}], "application_number": "ANDA200043", "marketing_category": "ANDA", "marketing_start_date": "20160601", "listing_expiration_date": "20261231"}