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United States · US · US:55513-516_d869faaf-a5ad-4b12-b427-06587d17787e
Otezla
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmgen, Inc
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155513516411 BLISTER PACK in 1 CARTON (55513-516-41) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
N205437
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"f6b1f516-4972-4d82-bced-113e47b41cc5": {
"match": "brand_token",
"title": "OTEZLA (APREMILAST) TABLET, FILM COATED OTEZLA (APREMILAST) KIT [AMGEN, INC]",
"spl_version": "34",
"published_date": "2026-01-23"
}
},
"productid": "55513-516_d869faaf-a5ad-4b12-b427-06587d17787e",
"productndc": "55513-516",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "205437",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Mar 21, 2014"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Mar 21, 2014"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "30MG",
"product_no": "003",
"approval_date": "Mar 21, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Otezla",
"active_ingred_unit": null,
"application_number": "NDA205437",
"marketing_category": "NDA",
"nonproprietary_name": "apremilast",
"start_marketing_date": "20200226",
"active_numerator_strength": null
}Access this data programmatically
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