roflumilast

Generic: roflumilast

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name roflumilast
Generic Name roflumilast
Labeler micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

roflumilast 500 ug/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-259
Product ID 42571-259_3aacb2a6-70a4-650d-e063-6394a90af9fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208180
Listing Expiration 2026-12-31
Marketing Start 2022-10-19

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 42571259
Hyphenated Format 42571-259

Supplemental Identifiers

RxCUI
1091839 2001319
UPC
0342571259327 0342571369835 0342571259303
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 ANDA208180 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 ug/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (42571-259-05)
  • 11 BLISTER PACK in 1 CARTON (42571-259-17) / 10 TABLET in 1 BLISTER PACK (42571-259-32)
  • 30 TABLET in 1 BOTTLE (42571-259-30)
  • 90 TABLET in 1 BOTTLE (42571-259-90)
source: ndc

Packages (4)

42571-259-05 500 TABLET in 1 BOTTLE (42571-259-05) 42571-259-17 11 BLISTER PACK in 1 CARTON (42571-259-17) / 10 TABLET in 1 BLISTER PACK (42571-259-32) 42571-259-30 30 TABLET in 1 BOTTLE (42571-259-30) 42571-259-90 90 TABLET in 1 BOTTLE (42571-259-90)

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": "3aacb2a6-70a4-650d-e063-6394a90af9fc", "openfda": {"nui": ["N0000182961", "N0000182960"], "upc": ["0342571259327", "0342571369835", "0342571259303"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839", "2001319"], "spl_set_id": ["dc2a689f-cfa4-4863-9623-a9813dcf86a9"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (42571-259-05)", "package_ndc": "42571-259-05", "marketing_start_date": "20221019"}, {"sample": false, "description": "11 BLISTER PACK in 1 CARTON (42571-259-17)  / 10 TABLET in 1 BLISTER PACK (42571-259-32)", "package_ndc": "42571-259-17", "marketing_start_date": "20221019"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (42571-259-30)", "package_ndc": "42571-259-30", "marketing_start_date": "20221019"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (42571-259-90)", "package_ndc": "42571-259-90", "marketing_start_date": "20221019"}], "brand_name": "ROFLUMILAST", "product_id": "42571-259_3aacb2a6-70a4-650d-e063-6394a90af9fc", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "42571-259", "generic_name": "Roflumilast", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROFLUMILAST", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "500 ug/1"}], "application_number": "ANDA208180", "marketing_category": "ANDA", "marketing_start_date": "20221019", "listing_expiration_date": "20261231"}