FDA.reportPublic FDA data

NDC 55513-517 - Otezla

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55513-517
Package NDCs from labels
55513-517-04
Manufacturer
Amgen, Inc | Celgene International Sarl
Effective date
2026-09-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Otezla - Amgen, Inc | Celgene International SarlAmgen, Inc | Celgene International Sarl2026-09-02HUMAN PRESCRIPTION DRUG LABEL

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 36 of 170 · 3,385 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RET Spleen/Pancreas 7002RET SPLEEN/PANCREASProfessional Complementary Health Formulasc6c82d50-0650-4cd9-85b9-c3cd422a35ce2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Vaccinosis Nosode 4004VACCINOSIS NOSODEProfessional Complementary Health Formulasdff675b3-6330-45d0-984c-526a8f44202b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Viral Immune Stimulator 6017VIRAL IMMUNE STIMULATORProfessional Complementary Health Formulasf462cfb7-e1c3-4ded-9f79-f1983517fe152026-01-08WarningsExact identifier
unii: 451W47IQ8X
Sinusitis Drops 2060SINUSITIS DROPSProfessional Complementary Health Formulas00469764-e0ab-45cf-8e61-6bdc67d31e542026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pituitary Liquescence 3018PITUITARY LIQUESCENCEProfessional Complementary Health Formulasa32e9ea9-5ff9-4951-9244-7b3253456b5f2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Large Ring Combination 9302LARGE RING COMBINATIONProfessional Complementary Health Formulascced8a69-7bc0-42ad-b80a-58fc603bf7652026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Domestic Animals Nosode Combination 9407DOMESTIC ANIMALS NOSODE COMBINATIONProfessional Complementary Health Formulas222c28aa-e07b-4706-9fb5-585b190f1c5b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum Combination 9237PSORINUM COMBINATIONProfessional Complementary Health Formulas8b2a133d-9681-4091-a6d1-4ecc4583626b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Adrenal Liquescence 3001ADRENAL LIQUESCENCEProfessional Complementary Health Formulas0388d3c7-4b3b-4e74-8c1b-9a2af2a4377d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
BADABOOM SUNSCREENSUNSCREENAopline Biotechnology (Guangzhou) Co., Ltd.47dbf363-2892-4530-e063-6294a90abe1f2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
ROE WELLNESS SPF 50 MINERALSPF 50 MINERAL POWDERAopline Biotechnology (Guangzhou) Co., Ltd.47dc8155-4abb-4bb7-e063-6294a90af1ad2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
ALOHA MINERAL BLOCK-BRUSH ON MINERALSUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.47dd07aa-71b4-5d54-e063-6394a90a41272026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
unii: 15FIX9V2JP
HM-B (EDIBLE VINEGAR)TITANIUM OXIDEDEMAND SERVICE, CO., LTD.9a7b1e74-b8af-449c-e053-2995a90a349e2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Polyvinyl Alcohol Eye Drops 1,4 % w/vPOLYVINYL ALCOHOL EYE DROPS 1,4 % W/VAurolabe8e09719-6e06-612b-e053-2995a90a79fc2026-01-08WarningsExact identifier
unii: 532B59J990
Anti-Constipation Drops 2077ANTI-CONSTIPATION DROPSProfessional Complementary Health Formulas55d105fe-5698-43a6-9252-eaa9b63299d02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anxious Drops 2098ANXIOUS DROPSProfessional Complementary Health Formulasa5dc8619-074a-4c1f-8bb2-fea788f5aff12026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus Liquescence 3023SPLEEN THYMUS LIQUESCENCEProfessional Complementary Health Formulasabe3c5c4-c5b4-47dd-afe3-b7858c82f7752026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Bladder 7006RET BLADDERProfessional Complementary Health Formulasf1d354e7-3d72-40aa-aaf1-172cb39f07112026-01-08WarningsExact identifier
unii: 451W47IQ8X
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.