roflumilast

Generic: roflumilast

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name roflumilast
Generic Name roflumilast
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

roflumilast 250 ug/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-624
Product ID 68382-624_70642eb6-1ced-4f90-85b2-7d4238c197d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208303
Listing Expiration 2026-12-31
Marketing Start 2023-05-18

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 68382624
Hyphenated Format 68382-624

Supplemental Identifiers

RxCUI
1091839 2001319
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 ANDA208303 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 ug/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (68382-624-31) / 28 TABLET in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (68382-624-83) / 10 TABLET in 1 BLISTER PACK (68382-624-30)
source: ndc

Packages (2)

68382-624-31 1 BLISTER PACK in 1 CARTON (68382-624-31) / 28 TABLET in 1 BLISTER PACK 68382-624-83 2 BLISTER PACK in 1 CARTON (68382-624-83) / 10 TABLET in 1 BLISTER PACK (68382-624-30)

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": "70642eb6-1ced-4f90-85b2-7d4238c197d0", "openfda": {"nui": ["N0000182961", "N0000182960"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839", "2001319"], "spl_set_id": ["84145572-f320-4c3f-ab29-bd9f6c18746c"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68382-624-31)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "68382-624-31", "marketing_start_date": "20230518"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (68382-624-83)  / 10 TABLET in 1 BLISTER PACK (68382-624-30)", "package_ndc": "68382-624-83", "marketing_start_date": "20230518"}], "brand_name": "Roflumilast", "product_id": "68382-624_70642eb6-1ced-4f90-85b2-7d4238c197d0", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "68382-624", "generic_name": "Roflumilast", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Roflumilast", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "250 ug/1"}], "application_number": "ANDA208303", "marketing_category": "ANDA", "marketing_start_date": "20230518", "listing_expiration_date": "20261231"}