otezla

Generic: apremilast

Labeler: amgen, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name otezla
Generic Name apremilast
Labeler amgen, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

apremilast 20 mg/1

Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-497
Product ID 55513-497_d869faaf-a5ad-4b12-b427-06587d17787e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205437
Listing Expiration 2027-12-31
Marketing Start 2024-04-25

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 55513497
Hyphenated Format 55513-497

Supplemental Identifiers

RxCUI
1492732 1492738 1492740 1492742 1492744 1492746 1492747 1492748 1605454 1605455 2682429 2682430 2682431 2682432 2723448 2723452 2724366 2724367
UPC
0355513137607
UNII
UP7QBP99PN
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 otezla (source: ndc)
Generic Name apremilast (source: ndc)
Application Number NDA205437 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (55513-497-60)
source: ndc

Packages (1)

55513-497-60 60 TABLET, FILM COATED in 1 BOTTLE (55513-497-60)

Ingredients (1)

apremilast (20 mg/1)

Linked Drug Pages (1)

Otezla ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d869faaf-a5ad-4b12-b427-06587d17787e", "openfda": {"nui": ["N0000182961", "N0000182960"], "upc": ["0355513137607"], "unii": ["UP7QBP99PN"], "rxcui": ["1492732", "1492738", "1492740", "1492742", "1492744", "1492746", "1492747", "1492748", "1605454", "1605455", "2682429", "2682430", "2682431", "2682432", "2723448", "2723452", "2724366", "2724367"], "spl_set_id": ["f6b1f516-4972-4d82-bced-113e47b41cc5"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Amgen, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (55513-497-60)", "package_ndc": "55513-497-60", "marketing_start_date": "20240427"}], "brand_name": "Otezla", "product_id": "55513-497_d869faaf-a5ad-4b12-b427-06587d17787e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "55513-497", "generic_name": "apremilast", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Otezla", "active_ingredients": [{"name": "APREMILAST", "strength": "20 mg/1"}], "application_number": "NDA205437", "marketing_category": "NDA", "marketing_start_date": "20240425", "listing_expiration_date": "20271231"}