roflumilast

Generic: roflumilast

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name roflumilast
Generic Name roflumilast
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

roflumilast 250 ug/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1673
Product ID 70771-1673_eb40db9e-ddc1-4041-aac5-ff0f2c478fc6
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 707711673
Hyphenated Format 70771-1673

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
  • 2 BLISTER PACK in 1 CARTON (70771-1673-3) / 10 TABLET in 1 BLISTER PACK (70771-1673-2)
  • 1 BLISTER PACK in 1 CARTON (70771-1673-8) / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

70771-1673-3 2 BLISTER PACK in 1 CARTON (70771-1673-3) / 10 TABLET in 1 BLISTER PACK (70771-1673-2) 70771-1673-8 1 BLISTER PACK in 1 CARTON (70771-1673-8) / 28 TABLET in 1 BLISTER PACK

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": "eb40db9e-ddc1-4041-aac5-ff0f2c478fc6", "openfda": {"nui": ["N0000182961", "N0000182960"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839", "2001319"], "spl_set_id": ["e87287bd-eae3-46c3-9072-04800aeabf40"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (70771-1673-3)  / 10 TABLET in 1 BLISTER PACK (70771-1673-2)", "package_ndc": "70771-1673-3", "marketing_start_date": "20230518"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70771-1673-8)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "70771-1673-8", "marketing_start_date": "20230518"}], "brand_name": "Roflumilast", "product_id": "70771-1673_eb40db9e-ddc1-4041-aac5-ff0f2c478fc6", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "70771-1673", "generic_name": "Roflumilast", "labeler_name": "Zydus Lifesciences Limited", "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"}