roflumilast

Generic: roflumilast

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name roflumilast
Generic Name roflumilast
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

roflumilast 250 ug/1

Manufacturer
MAJOR PHARMACEUTICALS

Identifiers & Regulatory

Product NDC 0904-7493
Product ID 0904-7493_44dcecac-a91b-4149-b030-d44e925bee4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208256
Listing Expiration 2026-12-31
Marketing Start 2025-10-27

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 09047493
Hyphenated Format 0904-7493

Supplemental Identifiers

RxCUI
1091839 2001319
UPC
0309047493715
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 ANDA208256 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 ug/1
source: ndc
Packaging
  • 28 TABLET in 1 BOTTLE (0904-7493-71)
source: ndc

Packages (1)

0904-7493-71 28 TABLET in 1 BOTTLE (0904-7493-71)

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": "44dcecac-a91b-4149-b030-d44e925bee4b", "openfda": {"nui": ["N0000182961", "N0000182960"], "upc": ["0309047493715"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839", "2001319"], "spl_set_id": ["c51b80f3-a591-4db9-81b4-b91603e35d7c"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["MAJOR PHARMACEUTICALS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET in 1 BOTTLE (0904-7493-71)", "package_ndc": "0904-7493-71", "marketing_start_date": "20251027"}], "brand_name": "Roflumilast", "product_id": "0904-7493_44dcecac-a91b-4149-b030-d44e925bee4b", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "0904-7493", "generic_name": "Roflumilast", "labeler_name": "MAJOR PHARMACEUTICALS", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Roflumilast", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "250 ug/1"}], "application_number": "ANDA208256", "marketing_category": "ANDA", "marketing_start_date": "20251027", "listing_expiration_date": "20261231"}