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 3 of 21 · 418 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
unii: 339NCG44TV
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: Q40Q9N063P
unii: K0U68Q2TXA
Free RadicalALFALFA, ASCORBYL PALMITATE, CYSTEINUM, DIMETHYL GLYCINE, FUCUS VESICULOSUS, HORDEUM VULGARE, L-METHIONINE, MANGANESE GLUCONATE, NASTURTIUM AQUATICUM, QUERCETIN, RAPHANUS SATIVUS, SODIUM SELENITE, TRITICUM AESTIVUM, UBIDECARENONUM, ALPHA-LIPOICUM ACIDUM, GABA (GAMMA AMINOBUTYRIC ACID), ORYZA SATIVA, VITAMIN E, ZINC PICOLINATE, COBALTUM METALLICUM, FERRUM METALLICUM, GLUTATHIONE, MAGNESIUM FLUORATUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUMDeseret Biologicals, Inc.36060680-f0d2-44c3-82fa-649e6e9d454d2026-05-06WarningsExact identifier
unii: K848JZ4886
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Diathesis IIIHEART (SUIS), SMALL INTESTINE (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, CYSTEINUM, MANGANUM METALLICUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, ARSENICUM ALBUM, AURUM METALLICUM, FUMARICUM ACIDUM, NATRUM OXALACETICUM, PHOSPHORUSBioActive Nutritional, Inc.d914f6d6-5008-4153-81d3-87a297ac5d202026-04-27WarningsExact identifier
unii: K848JZ4886
Coleman Bite and Sting ReliefEXTERNAL ANESTHETIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4fadf1f1-478a-5104-e063-6294a90a10cb2026-04-17WarningsExact identifier
unii: 339NCG44TV
Coleman Sting and Bite ReliefEXTERNAL ANALGESIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4f94ab35-3099-716c-e063-6294a90a8bea2026-04-16WarningsExact identifier
unii: 339NCG44TV
BiteMDINSECT BITE RELIEFWisconsin Pharmacal Company4f860c1e-a638-4923-e063-6294a90ae7e22026-04-15WarningsExact identifier
unii: 339NCG44TV
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
unii: 339NCG44TV
Sore throat cherryPHENOLWalgreens67bed85e-e1e2-49ba-98d6-dfd4e1cd68562026-04-08WarningsExact identifier
unii: 339NCG44TV
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Acetic AcidACETIC ACIDA-S Medication Solutionsc1c28375-9b03-4590-9d39-ab28403da93d2026-03-18Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Weight Loss Support Plus AdrenalGLYCYRRHIZA GLABRA, FOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), ARALIA QUINQUEFOLIA, CAPSICUM ANNUUM, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM (NSPC), PHYTOLACCA DECANDRA, THYROIDINUM (BOVINE), GLANDULA SUPRARENALIS (BOVINE), PITUITARUM POSTERIUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUS, ADRENOCORTICOTROPHINCarolinas Weight Loss Institutefd0b6097-e886-410c-acf8-fff475677af82026-03-09WarningsExact identifier
unii: K0U68Q2TXA
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Upper Gi and Enzyme RestorationACETICUM ACIDUM, AGARICUS MUSCARIUS, ALOE, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINCHONA OFFICINALIS, GRAPHITES, IPECACUANHA, LAC DEFLORATUM, MENTHA PIPERITA, NUX VOMICA, SECALE CORNUTUM, TANACETUM VULGARE, TEUCRIUM MARUM AND ZINGIBER OFFICINALE.King Bio Inc.84e268e5-ba68-4ad6-84d4-d799c4ea91ee2026-03-04WarningsExact identifier
unii: Q40Q9N063P

Reported adverse events (FAERS/openFDA)#

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