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 500 ug/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-969
Product ID 68382-969_70642eb6-1ced-4f90-85b2-7d4238c197d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208303
Listing Expiration 2026-12-31
Marketing Start 2022-10-03

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 68382969
Hyphenated Format 68382-969

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
  • 500 ug/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68382-969-06)
  • 90 TABLET in 1 BOTTLE (68382-969-16)
source: ndc

Packages (2)

68382-969-06 30 TABLET in 1 BOTTLE (68382-969-06) 68382-969-16 90 TABLET in 1 BOTTLE (68382-969-16)

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": "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": "30 TABLET in 1 BOTTLE (68382-969-06)", "package_ndc": "68382-969-06", "marketing_start_date": "20221003"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-969-16)", "package_ndc": "68382-969-16", "marketing_start_date": "20221003"}], "brand_name": "Roflumilast", "product_id": "68382-969_70642eb6-1ced-4f90-85b2-7d4238c197d0", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "68382-969", "generic_name": "Roflumilast", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Roflumilast", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "500 ug/1"}], "application_number": "ANDA208303", "marketing_category": "ANDA", "marketing_start_date": "20221003", "listing_expiration_date": "20261231"}