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 KIT
Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-508
Product ID 55513-508_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 55513508
Hyphenated Format 55513-508

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: label

Resolved Composition

Strengths
  • 75 mg
  • 10 mg
  • 20 mg
  • 30 mg
source: label
Packaging
  • 1 KIT in 1 BLISTER PACK (55513-508-55) * 51 TABLET, FILM COATED in 1 BLISTER PACK (55513-497-51) * 4 TABLET, FILM COATED in 1 BLISTER PACK (55513-518-04)
source: ndc

Packages (1)

55513-508-55 1 KIT in 1 BLISTER PACK (55513-508-55) * 51 TABLET, FILM COATED in 1 BLISTER PACK (55513-497-51) * 4 TABLET, FILM COATED in 1 BLISTER PACK (55513-518-04)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Otezla ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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": "1 KIT in 1 BLISTER PACK (55513-508-55)  *  51 TABLET, FILM COATED in 1 BLISTER PACK (55513-497-51)  *  4 TABLET, FILM COATED in 1 BLISTER PACK (55513-518-04)", "package_ndc": "55513-508-55", "marketing_start_date": "20240427"}], "brand_name": "Otezla", "product_id": "55513-508_d869faaf-a5ad-4b12-b427-06587d17787e", "dosage_form": "KIT", "product_ndc": "55513-508", "generic_name": "apremilast", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Otezla", "application_number": "NDA205437", "marketing_category": "NDA", "marketing_start_date": "20240425", "listing_expiration_date": "20271231"}