roflumilast

Generic: ROFLUMILAST

Labeler: Strides Pharma Science Limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name roflumilast
Generic Name ROFLUMILAST
Labeler Strides Pharma Science Limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ROFLUMILAST 250 ug/1

Identifiers & Regulatory

Product NDC 64380-287
Product ID 64380-287_43c27e68-4072-46c5-9f03-f02b3288a95d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208247
Listing Expiration 2027-12-31
Marketing Start 2025-07-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380287
Hyphenated Format 64380-287

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 ANDA208247 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 ug/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (64380-287-02) / 14 TABLET in 1 BLISTER PACK (64380-287-01)
source: ndc

Packages (1)

64380-287-02 2 BLISTER PACK in 1 CARTON (64380-287-02) / 14 TABLET in 1 BLISTER PACK (64380-287-01)

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": "43c27e68-4072-46c5-9f03-f02b3288a95d", "openfda": {"nui": ["N0000182961", "N0000182960"], "upc": ["0364380786054", "0364380786016"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839", "2001319"], "spl_set_id": ["78d2644d-b62c-48f5-8407-2adf09bcb144"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (64380-287-02)  / 14 TABLET in 1 BLISTER PACK (64380-287-01)", "package_ndc": "64380-287-02", "marketing_start_date": "20250703"}], "brand_name": "roflumilast", "product_id": "64380-287_43c27e68-4072-46c5-9f03-f02b3288a95d", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "64380-287", "generic_name": "ROFLUMILAST", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "roflumilast", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "250 ug/1"}], "application_number": "ANDA208247", "marketing_category": "ANDA", "marketing_start_date": "20250703", "listing_expiration_date": "20271231"}