roflumilast

Generic: roflumilast

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name roflumilast
Generic Name roflumilast
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

roflumilast 500 ug/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-480
Product ID 67877-480_955dd6eb-46f6-4c73-bcc8-bfd7b14ebc98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212490
Listing Expiration 2026-12-31
Marketing Start 2025-03-14

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 67877480
Hyphenated Format 67877-480

Supplemental Identifiers

RxCUI
1091839 2001319
UPC
0367877730936
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 ANDA212490 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 ug/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (67877-480-05)
  • 30 TABLET in 1 BOTTLE (67877-480-30)
  • 1 BLISTER PACK in 1 CARTON (67877-480-33) / 10 TABLET in 1 BLISTER PACK
  • 90 TABLET in 1 BOTTLE (67877-480-90)
source: ndc

Packages (4)

67877-480-05 500 TABLET in 1 BOTTLE (67877-480-05) 67877-480-30 30 TABLET in 1 BOTTLE (67877-480-30) 67877-480-33 1 BLISTER PACK in 1 CARTON (67877-480-33) / 10 TABLET in 1 BLISTER PACK 67877-480-90 90 TABLET in 1 BOTTLE (67877-480-90)

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": "955dd6eb-46f6-4c73-bcc8-bfd7b14ebc98", "openfda": {"nui": ["N0000182961", "N0000182960"], "upc": ["0367877730936"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839", "2001319"], "spl_set_id": ["93d72a99-64dc-4fde-a5b8-78331fa60787"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (67877-480-05)", "package_ndc": "67877-480-05", "marketing_start_date": "20250314"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (67877-480-30)", "package_ndc": "67877-480-30", "marketing_start_date": "20250314"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (67877-480-33)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "67877-480-33", "marketing_start_date": "20250314"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (67877-480-90)", "package_ndc": "67877-480-90", "marketing_start_date": "20250314"}], "brand_name": "Roflumilast", "product_id": "67877-480_955dd6eb-46f6-4c73-bcc8-bfd7b14ebc98", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "67877-480", "generic_name": "Roflumilast", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Roflumilast", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "500 ug/1"}], "application_number": "ANDA212490", "marketing_category": "ANDA", "marketing_start_date": "20250314", "listing_expiration_date": "20261231"}