roflumilast

Generic: roflumilast

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name roflumilast
Generic Name roflumilast
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

roflumilast 500 ug/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2385
Product ID 72162-2385_f086d8f9-3cf8-4196-a422-c4117bd1fcaf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208180
Listing Expiration 2026-12-31
Marketing Start 2022-10-19

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 721622385
Hyphenated Format 72162-2385

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 ANDA208180 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 ug/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72162-2385-3)
source: ndc

Packages (1)

72162-2385-3 30 TABLET in 1 BOTTLE (72162-2385-3)

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": "f086d8f9-3cf8-4196-a422-c4117bd1fcaf", "openfda": {"nui": ["N0000182961", "N0000182960"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839"], "spl_set_id": ["fa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72162-2385-3)", "package_ndc": "72162-2385-3", "marketing_start_date": "20240815"}], "brand_name": "ROFLUMILAST", "product_id": "72162-2385_f086d8f9-3cf8-4196-a422-c4117bd1fcaf", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "72162-2385", "generic_name": "Roflumilast", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROFLUMILAST", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "500 ug/1"}], "application_number": "ANDA208180", "marketing_category": "ANDA", "marketing_start_date": "20221019", "listing_expiration_date": "20261231"}