armodafinil

Generic: armodafinil

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name armodafinil
Generic Name armodafinil
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

armodafinil 50 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-805
Product ID 65862-805_09746c0a-9656-4f1d-a380-1cbe732c8e21
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206069
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2018-03-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862805
Hyphenated Format 65862-805

Supplemental Identifiers

RxCUI
724859 724861 724863 861960
UPC
0365862807304 0365862805300
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 ANDA206069 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (65862-805-05)
  • 30 TABLET in 1 BOTTLE (65862-805-30)
  • 60 TABLET in 1 BOTTLE (65862-805-60)
source: ndc

Packages (3)

65862-805-05 500 TABLET in 1 BOTTLE (65862-805-05) 65862-805-30 30 TABLET in 1 BOTTLE (65862-805-30) 65862-805-60 60 TABLET in 1 BOTTLE (65862-805-60)

Ingredients (1)

armodafinil (50 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": "09746c0a-9656-4f1d-a380-1cbe732c8e21", "openfda": {"upc": ["0365862807304", "0365862805300"], "unii": ["V63XWA605I"], "rxcui": ["724859", "724861", "724863", "861960"], "spl_set_id": ["23da56b8-7552-4362-a1ab-e794c131194c"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (65862-805-05)", "package_ndc": "65862-805-05", "marketing_start_date": "20180306"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65862-805-30)", "package_ndc": "65862-805-30", "marketing_start_date": "20180306"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (65862-805-60)", "package_ndc": "65862-805-60", "marketing_start_date": "20180306"}], "brand_name": "Armodafinil", "product_id": "65862-805_09746c0a-9656-4f1d-a380-1cbe732c8e21", "dosage_form": "TABLET", "product_ndc": "65862-805", "dea_schedule": "CIV", "generic_name": "Armodafinil", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Armodafinil", "active_ingredients": [{"name": "ARMODAFINIL", "strength": "50 mg/1"}], "application_number": "ANDA206069", "marketing_category": "ANDA", "marketing_start_date": "20180306", "listing_expiration_date": "20261231"}