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 4 of 21 · 418 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
unii: 339NCG44TV
911 Adrenal Burnout and FatigueACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM.King Bio Inc.21c6b6c1-e846-4f25-a1dc-02e79d1be7562026-02-26WarningsExact identifier
unii: Q40Q9N063P
unii: K0U68Q2TXA
Appetite and Weight with P.H.A.T.ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, CASTANEA SATIVA, FLOS, CORTISONE ACETICUM, FUCUS VESICULOSUS, HYPOTHALAMUS, KALI BICHROMICUM, OLEANDER, PITUITARUM POSTERIUM, SABADILLA, STAPHYSAGRIA, AND THYROIDINUM.King Bio Inc.80958e8e-f868-44c9-b99f-57faf0e97e012026-02-26WarningsExact identifier
unii: K0U68Q2TXA
SIGNATURE CARE SORE THROAT CHERRY FLAVORPHENOLSAFEWAY94a2c1b9-f462-4489-b84a-825a82835d302026-02-23WarningsExact identifier
unii: 339NCG44TV
Mold PlusAGARICUS MUSCARIUS, ALLIUM CEPA, AMMONIUM CARBONICUM, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, ASPERGILLUS NIGER, BLATTA ORIENTALIS, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), FERRUM METALLICUM, KALI CARBONICUM, MEPHITIS MEPHITICA, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, SANGUINARIA CANADENSIS, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.372ad9cc-70eb-4f3f-b611-69e2d157c0582026-02-23WarningsExact identifier
unii: 339NCG44TV
Grass and Weed MixGLANDULA SUPRARENALIS (BOVINE), HEPAR (BOVINE), HISTAMINUM HYDROCHLORICUM, BAHIA GRASS, BERMUDA GRASS, BROME GRASS POLLEN, CORN POLLEN, JOHNSON GRASS, KENTUCKY BLUEGRASS, MEADOW FESCUE POLLEN, OATS POLLEN, ORCHARD GRASS, RYE GRASS, TIMOTHY GRASS, VERNAL GRASS, WHEAT GRASS POLLEN, COCKLEBUR POLLEN, GOLDENROD POLLEN, LAMBS QUARTERS POLLEN, MUGWORT POLLEN, MUSTARD POLLEN, RAGWEED POLLEN, RED CLOVER POLLEN, YELLOW DOCK POLLEN, ADRENOCORTICOTROPHINNutritional Specialties, Inc.9d1e4e1d-5db9-4dc5-afdd-910bc5f6a7ca2026-02-20WarningsExact identifier
unii: K0U68Q2TXA
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: K848JZ4886
Red Oil Pain ReliefCAMPHOR (SYNTHETIC), MENTHOL, PHENOLThe Red Oil Company Inc1e36579a-72da-46ba-ac72-5960a11c08802026-01-29WarningsExact identifier
unii: 339NCG44TV
FUNGAL NAIL TREATMENTFUNGAL NAIL TREATMENTJiangxi He-Oumei Health Industry Co., Ltd.4922f627-167a-1783-e063-6394a90acd6f2026-01-24WarningsExact identifier
unii: Q40Q9N063P
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare46b84e0b-78a9-4cde-9f90-e165b54191622026-01-09WarningsExact identifier
unii: 339NCG44TV
E.O.L.STILLINGIA SYLVATICA, ZINCUM GLUCONICUM, THIAMINUM HYDROCHLORICUM, FRAGARIA VESCA, NICOTINAMIDUM, RHEUM (PALMATUM), SEROTONIN (HYDROCHLORIDE), 5-HYDROXYTRYPTOPHAN, BETAINUM MURIATICUM, BIOTIN, CHOLINUM, CYSTEINUM, DL-METHIONINE, L-ALANINE, L-CYSTINE, L-GLUTAMIC ACID, L-GLUTAMINE, L-LYSINE, L-METHIONINE, L-SERINE, PARA-AMINOBENZOIC ACID, POTASSIUM GLUCONATE, THYMUS (SUIS), THYROIDINUM (SUIS), UBIDECARENONUM, VITAMIN D3, DOPAMINE HYDROCHLORIDE, LITHIUM BROMATUM, SQUALENE, VACCINIUM MACROCARPON, OXYTOCIN,InLight Creation, LLC.b317d812-d6ed-4a2f-93f7-08b12261cc992026-01-09WarningsExact identifier
unii: K848JZ4886
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: K848JZ4886
Trees 1 1016TREES 1Professional Complementary Health Formulas7c5824f2-6c8f-418d-97b0-69c62db18ab72026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Growth Hormone Drops 2160GROWTH HORMONE DROPSProfessional Complementary Health Formulas56536a40-febe-4856-8a74-ed96a7e5a5c32026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Vegetable Mix 1018VEGETABLE MIXProfessional Complementary Health Formulas2c32ead6-5ee5-439f-9e7a-adf268a0cbe12026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Caffeine Mix 1003CAFFEINE MIXProfessional Complementary Health Formulasce7f9a40-6cb1-49d1-a36a-e0f292dd136e2026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Smoke Mix 1023SMOKE MIXProfessional Complementary Health Formulas29c4fb6c-ce90-4f07-94e9-9902b17a3c662026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Southeast Regional 1024SOUTHEAST REGIONALProfessional Complementary Health Formulas7a4ff3cf-6897-4cca-b907-556270642e042026-01-08WarningsExact identifier
unii: K0U68Q2TXA

Reported adverse events (FAERS/openFDA)#

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