roflumilast

Generic: roflumilast

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name roflumilast
Generic Name roflumilast
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

roflumilast 250 ug/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-676
Product ID 31722-676_fa61de4b-e3e1-e16c-e053-6394a90a6118
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208213
Listing Expiration 2026-12-31
Marketing Start 2023-04-18

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 31722676
Hyphenated Format 31722-676

Supplemental Identifiers

RxCUI
1091839 2001319
UPC
0331722623902 0331722623308
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 ANDA208213 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 ug/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (31722-676-32) / 10 TABLET in 1 BLISTER PACK (31722-676-31)
  • 1 BLISTER PACK in 1 CARTON (31722-676-36) / 28 TABLET in 1 BLISTER PACK (31722-676-35)
source: ndc

Packages (2)

31722-676-32 2 BLISTER PACK in 1 CARTON (31722-676-32) / 10 TABLET in 1 BLISTER PACK (31722-676-31) 31722-676-36 1 BLISTER PACK in 1 CARTON (31722-676-36) / 28 TABLET in 1 BLISTER PACK (31722-676-35)

Ingredients (1)

roflumilast (250 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": "fa61de4b-e3e1-e16c-e053-6394a90a6118", "openfda": {"nui": ["N0000182961", "N0000182960"], "upc": ["0331722623902", "0331722623308"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839", "2001319"], "spl_set_id": ["f25a0230-3cf6-4366-bebe-0ea5ff8de5ab"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (31722-676-32)  / 10 TABLET in 1 BLISTER PACK (31722-676-31)", "package_ndc": "31722-676-32", "marketing_start_date": "20230418"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (31722-676-36)  / 28 TABLET in 1 BLISTER PACK (31722-676-35)", "package_ndc": "31722-676-36", "marketing_start_date": "20230418"}], "brand_name": "Roflumilast", "product_id": "31722-676_fa61de4b-e3e1-e16c-e053-6394a90a6118", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "31722-676", "generic_name": "Roflumilast", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Roflumilast", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "250 ug/1"}], "application_number": "ANDA208213", "marketing_category": "ANDA", "marketing_start_date": "20230418", "listing_expiration_date": "20261231"}