roflumilast

Generic: roflumilast

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name roflumilast
Generic Name roflumilast
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

roflumilast 250 ug/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-201
Product ID 72205-201_b56e7d3f-9930-43fa-baf4-63f9cee750f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208256
Listing Expiration 2026-12-31
Marketing Start 2022-09-07

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 72205201
Hyphenated Format 72205-201

Supplemental Identifiers

RxCUI
1091839 2001319
UPC
0372205200302 0372205200906 0372205201309
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 ANDA208256 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 ug/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (72205-201-24) / 10 TABLET in 1 BLISTER PACK (72205-201-11)
  • 30 TABLET in 1 BOTTLE (72205-201-30)
  • 2 BLISTER PACK in 1 CARTON (72205-201-32) / 14 TABLET in 1 BLISTER PACK (72205-201-13)
source: ndc

Packages (3)

72205-201-24 2 BLISTER PACK in 1 CARTON (72205-201-24) / 10 TABLET in 1 BLISTER PACK (72205-201-11) 72205-201-30 30 TABLET in 1 BOTTLE (72205-201-30) 72205-201-32 2 BLISTER PACK in 1 CARTON (72205-201-32) / 14 TABLET in 1 BLISTER PACK (72205-201-13)

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": "b56e7d3f-9930-43fa-baf4-63f9cee750f2", "openfda": {"nui": ["N0000182961", "N0000182960"], "upc": ["0372205200302", "0372205200906", "0372205201309"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839", "2001319"], "spl_set_id": ["4d25f69c-58b7-4e2a-b835-4d0c76a83c7c"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (72205-201-24)  / 10 TABLET in 1 BLISTER PACK (72205-201-11)", "package_ndc": "72205-201-24", "marketing_start_date": "20220924"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72205-201-30)", "package_ndc": "72205-201-30", "marketing_start_date": "20221221"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (72205-201-32)  / 14 TABLET in 1 BLISTER PACK (72205-201-13)", "package_ndc": "72205-201-32", "marketing_start_date": "20220924"}], "brand_name": "Roflumilast", "product_id": "72205-201_b56e7d3f-9930-43fa-baf4-63f9cee750f2", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "72205-201", "generic_name": "Roflumilast", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Roflumilast", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "250 ug/1"}], "application_number": "ANDA208256", "marketing_category": "ANDA", "marketing_start_date": "20220907", "listing_expiration_date": "20261231"}