roflumilast

Generic: roflumilast

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

Drug Facts

Product Profile

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

roflumilast 250 ug/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-801
Product ID 59651-801_586e58c7-172f-4c3f-a91f-045ea4d089fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213298
Listing Expiration 2026-12-31
Marketing Start 2025-01-31

Pharmacologic Class

Established (EPC)
phosphodiesterase 4 inhibitor [epc]
Mechanism of Action
phosphodiesterase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651801
Hyphenated Format 59651-801

Supplemental Identifiers

RxCUI
1091839 2001319
UNII
0P6C6ZOP5U
NUI
N0000182961 N0000182960

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 roflumilast (source: ndc)
Generic Name roflumilast (source: ndc)
Application Number ANDA213298 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 ug/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (59651-801-20) / 20 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (59651-801-28) / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

59651-801-20 1 BLISTER PACK in 1 CARTON (59651-801-20) / 20 TABLET in 1 BLISTER PACK 59651-801-28 1 BLISTER PACK in 1 CARTON (59651-801-28) / 28 TABLET in 1 BLISTER PACK

Ingredients (1)

roflumilast (250 ug/1)

Linked Drug Pages (1)

ROFLUMILAST ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "586e58c7-172f-4c3f-a91f-045ea4d089fc", "openfda": {"nui": ["N0000182961", "N0000182960"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839", "2001319"], "spl_set_id": ["7cb11d48-6bb9-437b-bc7f-382050a2d3e6"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59651-801-20)  / 20 TABLET in 1 BLISTER PACK", "package_ndc": "59651-801-20", "marketing_start_date": "20250131"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59651-801-28)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "59651-801-28", "marketing_start_date": "20250131"}], "brand_name": "ROFLUMILAST", "product_id": "59651-801_586e58c7-172f-4c3f-a91f-045ea4d089fc", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "59651-801", "generic_name": "ROFLUMILAST", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROFLUMILAST", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "250 ug/1"}], "application_number": "ANDA213298", "marketing_category": "ANDA", "marketing_start_date": "20250131", "listing_expiration_date": "20261231"}