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 500 ug/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-275
Product ID 59651-275_586e58c7-172f-4c3f-a91f-045ea4d089fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213298
Listing Expiration 2026-12-31
Marketing Start 2023-04-17

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 59651275
Hyphenated Format 59651-275

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
  • 500 ug/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (59651-275-30)
  • 90 TABLET in 1 BOTTLE (59651-275-90)
source: ndc

Packages (2)

59651-275-30 30 TABLET in 1 BOTTLE (59651-275-30) 59651-275-90 90 TABLET in 1 BOTTLE (59651-275-90)

Ingredients (1)

roflumilast (500 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": "30 TABLET in 1 BOTTLE (59651-275-30)", "package_ndc": "59651-275-30", "marketing_start_date": "20230417"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (59651-275-90)", "package_ndc": "59651-275-90", "marketing_start_date": "20230417"}], "brand_name": "ROFLUMILAST", "product_id": "59651-275_586e58c7-172f-4c3f-a91f-045ea4d089fc", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "59651-275", "generic_name": "ROFLUMILAST", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROFLUMILAST", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "500 ug/1"}], "application_number": "ANDA213298", "marketing_category": "ANDA", "marketing_start_date": "20230417", "listing_expiration_date": "20261231"}