roflumilast

Generic: roflumilast

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name roflumilast
Generic Name roflumilast
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

roflumilast 500 ug/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-786
Product ID 60687-786_276fef08-9f1c-11d8-e063-6294a90af500
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208213
Listing Expiration 2026-12-31
Marketing Start 2023-12-07

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 60687786
Hyphenated Format 60687-786

Supplemental Identifiers

RxCUI
1091839
UNII
0P6C6ZOP5U
NUI
N0000182961 N0000182960

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 ANDA208213 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 ug/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (60687-786-21) / 1 TABLET in 1 BLISTER PACK (60687-786-11)
source: ndc

Packages (1)

60687-786-21 30 BLISTER PACK in 1 CARTON (60687-786-21) / 1 TABLET in 1 BLISTER PACK (60687-786-11)

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": "276fef08-9f1c-11d8-e063-6294a90af500", "openfda": {"nui": ["N0000182961", "N0000182960"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839"], "spl_set_id": ["913f1b95-9c46-40d5-a6e9-cff2e5e07eaa"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (60687-786-21)  / 1 TABLET in 1 BLISTER PACK (60687-786-11)", "package_ndc": "60687-786-21", "marketing_start_date": "20231207"}], "brand_name": "Roflumilast", "product_id": "60687-786_276fef08-9f1c-11d8-e063-6294a90af500", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "60687-786", "generic_name": "Roflumilast", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Roflumilast", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "500 ug/1"}], "application_number": "ANDA208213", "marketing_category": "ANDA", "marketing_start_date": "20231207", "listing_expiration_date": "20261231"}