FDA.reportPublic FDA data

NDC 63004-8712-01 - Acthar

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
63004-8712
Requested NDC
63004-8712-01
Package NDCs from labels
63004-8712-1, 63004-8712-4, 63004-8712-01
Manufacturer
Keenova ARD LLC
Effective date
2026-10-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acthar - Keenova ARD LLCKeenova ARD LLC2026-10-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63004-8712-1Acthar0.5 mL in 1 SYRINGEINJECTION0.528
63004-8712-1Acthar1 in 1 TRAYINJECTION128
63004-8712-4Acthar4 in 1 CARTONINJECTION428

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63004-8712ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD LLC]25Current NDC, 3 package rows20241220_7b48ddec-e815-45f4-9ca0-5c0daaf56f30.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63004-8712-1ML - Milliliter63004-8712f74d0c94-8cc9-4475-b682-735aad2d0e6012024-07-12
63004-8712-4ML - Milliliter63004-8712db39000e-0841-426e-9d86-a4f0815cd92812024-07-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CORTICOTROPINACTIVE INGREDIENTK0U68Q2TXAH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
CORTICOTROPINACTIVE MOIETYK0U68Q2TXAH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
CYSTEINEINACTIVE INGREDIENTK848JZ4886H.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
GELATININACTIVE INGREDIENT2G86QN327LH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
PHENOLINACTIVE INGREDIENT339NCG44TVH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3

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 9 of 21 · 418 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Thinnr BOOSTADEPS SUILLUS, ANDRENALINUM, ADRENOCORTICOTROPHIN, CALCAREA CARBONICA, CHELIDONIUM, PITUITARUM, THYROIDINUMSLIMCELL, LLC2bda8ba9-8626-aafd-e063-6294a90adbe82025-08-20WarningsExact identifier
unii: K0U68Q2TXA
Thinnr PROTOCOLADEPS SUILLUS, ADRENALINIUM, ADRENOCORTICOTROPHIN, AGRIMONIA EUPATORIA FLOS, AMMOUNIUM BROMATUM, ANACARDIUM ORIENTALE, ANTIMONIUM CRUDUM, CASTANEA SATIVA FLOS, CALCAREA CARBONICA, COENZYME A, CORTISONE ACETICUM, FUCUS VESICULOSUS, HYPOTHALAMUS, KALI BICHROMICUM, PITUITARUM POSTERIUM, RNA, SABADILLA, STAPHYSAGRIA, THYROIDINUMSLIMCELL, LLC2c162603-5861-9be0-e063-6294a90ade282025-08-20WarningsExact identifier
unii: K0U68Q2TXA
Aseptil RojoPHENOLMenper Distributors, Inc.62c96dc1-4698-43c1-8e6d-f4062dc5eea22025-07-22WarningsExact identifier
unii: 339NCG44TV
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: Q40Q9N063P
DENTAL-CHORDACETICUM ACIDUM, AMMONIUM MURIATICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARBOLICUM ACIDUM, CITRUS LIMONUM, CUPRUM METALLICUM, FERRUM METALLICUM, GLYCYRRHIZA GLABRA, LAPPA MAJOR, MEDULLA OSSIS SUIS, MERCURIUS SOLUBILIS, MYRRHA, NATRUM FLUORATUM, PALLADIUM METALLICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA, STANNUM METALLICUM, STAPHYSAGRIA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, X-RAY, ZINCUM OXYDATUMEnergetix Corporation6c9ba926-7c35-49fd-94d8-988ca0bb772c2025-07-15WarningsExact identifier
unii: Q40Q9N063P
unii: 339NCG44TV
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hydrocortisone and Acetic AcidHYDROCORTISONE AND ACETIC ACIDSun Pharmaceutical Industries, Inc.6383c722-84e2-4719-a13d-19c54e3eefff2025-07-07Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
QUALITY CHOICE Sore ThroatPHENOLCHAIN DRUG MARKETING ASSOCIATIONc95ee086-f384-475d-ad0c-75518cb9d2fe2025-06-10WarningsExact identifier
unii: 339NCG44TV
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MYCCombinationALLIUM CEPA, ECHINACEA (ECHINACEA ANGUSTIFOLIA), NATRUM SULPHURICUM, KALI CARBONICUM, SANGUINARIA CANADENSIS, AGARICUS MUSCARIUS, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, PHYTOLACCA DECANDRA, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALIS, AMMONIUM CARBONICUM, ASPERGILLUS NIGER, BLATTA ORIENTALIS, MEPHITIS MEPHITICADeseret Biologicals, Inc.22b6a444-68de-43a3-85e8-e8a74b3914bc2025-05-27WarningsExact identifier
unii: 339NCG44TV
MetDetoxALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, TANTALUM METALLICUM, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM,Dr. Donna Restivo DC89ce5e89-c592-445e-92f9-365133005fb32025-05-23WarningsExact identifier
unii: 339NCG44TV
unii: K848JZ4886
Household Dust and Mold MixGLANDULA SUPRARENALIS (BOVINE), HEPAR (BOVINE), HISTAMINUM HYDROCHLORICUM, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, DUST, MUCOR RACEMOSUS, TORULA CEREVISIAE, HOUSE DUST MITE, ADRENOCORTICOTROPHIN, RHIZOPUS NIGRICANSNutritional Specialties, Inc.39ce30c9-427c-4e6a-a918-d5478e38b6092025-05-15WarningsExact identifier
unii: K0U68Q2TXA

Reported adverse events (FAERS/openFDA)#

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