roflumilast

Generic: roflumilast

Labeler: solco healthcare us, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name roflumilast
Generic Name roflumilast
Labeler solco healthcare us, llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

roflumilast 500 ug/1

Manufacturer
Solco Healthcare US, LLC.

Identifiers & Regulatory

Product NDC 43547-005
Product ID 43547-005_4251c764-7224-4f94-9de7-b6c76cb1f5cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208299
Listing Expiration 2026-12-31
Marketing Start 2022-05-10

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 43547005
Hyphenated Format 43547-005

Supplemental Identifiers

RxCUI
1091839
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 ANDA208299 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 ug/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43547-005-03)
  • 90 TABLET in 1 BOTTLE (43547-005-09)
source: ndc

Packages (2)

43547-005-03 30 TABLET in 1 BOTTLE (43547-005-03) 43547-005-09 90 TABLET in 1 BOTTLE (43547-005-09)

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": "4251c764-7224-4f94-9de7-b6c76cb1f5cd", "openfda": {"nui": ["N0000182961", "N0000182960"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839"], "spl_set_id": ["4251c764-7224-4f94-9de7-b6c76cb1f5cd"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Solco Healthcare US, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43547-005-03)", "package_ndc": "43547-005-03", "marketing_start_date": "20220510"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43547-005-09)", "package_ndc": "43547-005-09", "marketing_start_date": "20220510"}], "brand_name": "ROFLUMILAST", "product_id": "43547-005_4251c764-7224-4f94-9de7-b6c76cb1f5cd", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "43547-005", "generic_name": "roflumilast", "labeler_name": "Solco Healthcare US, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROFLUMILAST", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "500 ug/1"}], "application_number": "ANDA208299", "marketing_category": "ANDA", "marketing_start_date": "20220510", "listing_expiration_date": "20261231"}