roflumilast

Generic: roflumilast

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

Drug Facts

Product Profile

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

roflumilast 500 ug/1

Identifiers & Regulatory

Product NDC 64380-786
Product ID 64380-786_9c3f4a61-0aed-418d-b77f-a1864bedee71
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208247
Listing Expiration 2027-12-31
Marketing Start 2022-10-13

Pharmacologic Class

Classes
phosphodiesterase 4 inhibitor [epc] phosphodiesterase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380786
Hyphenated Format 64380-786

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
  • 500 ug/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (64380-786-01)
  • 90 TABLET in 1 BOTTLE (64380-786-05)
source: ndc

Packages (2)

64380-786-01 30 TABLET in 1 BOTTLE (64380-786-01) 64380-786-05 90 TABLET in 1 BOTTLE (64380-786-05)

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": "9c3f4a61-0aed-418d-b77f-a1864bedee71", "openfda": {}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (64380-786-01)", "package_ndc": "64380-786-01", "marketing_start_date": "20221013"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (64380-786-05)", "package_ndc": "64380-786-05", "marketing_start_date": "20221013"}], "brand_name": "roflumilast", "product_id": "64380-786_9c3f4a61-0aed-418d-b77f-a1864bedee71", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "64380-786", "generic_name": "ROFLUMILAST", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "roflumilast", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "500 ug/1"}], "application_number": "ANDA208247", "marketing_category": "ANDA", "marketing_start_date": "20221013", "listing_expiration_date": "20271231"}