FDA.reportPublic FDA data

NDC 63004-8710-01 - 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
63004-8710
Requested NDC
63004-8710-01
Package NDCs from labels
63004-8710-1, 63004-8710-2, 63004-8710-01
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
63004-8710-1Acthar1 in 1 CARTONINJECTION128
63004-8710-1Acthar5 mL in 1 VIAL, MULTI-DOSEINJECTION528
63004-8710-2Acthar5 mL in 1 VIAL, MULTI-DOSEINJECTION528
63004-8710-2Acthar1 in 1 CARTONINJECTION128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63004-8710ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD LLC]25Current NDC, Legacy NDC, 4 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
63004-8710-1ML - Milliliter63004-8710f5c8b1a1-96a0-4f17-a791-56e95a217fc112013-02-13

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 5 of 21 · 418 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trees 2 1017TREES 2Professional Complementary Health Formulas601c8ffe-35c2-4dcc-a503-7d9b9998e2842026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Pituitary Liquescence 3018PITUITARY LIQUESCENCEProfessional Complementary Health Formulasa32e9ea9-5ff9-4951-9244-7b3253456b5f2026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Adrenal Liquescence 3001ADRENAL LIQUESCENCEProfessional Complementary Health Formulas0388d3c7-4b3b-4e74-8c1b-9a2af2a4377d2026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Flowers 1008FLOWERSProfessional Complementary Health Formulas6a9365e5-a815-4805-87ba-329945b5da3f2026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Castellani Paint 1.5%PHENOLThe Podiatree Companya10f18e0-b47c-424b-847e-bcc25aa250a42026-01-08WarningsExact identifier
unii: 339NCG44TV
Castellani Paint 1.5%PHENOLThe Podiatree Company5b8cff3c-71d2-418f-a43d-f570aa5408fd2026-01-08WarningsExact identifier
unii: 339NCG44TV
Fortinia IDPHENOLThe Podiatree Company60c88eb7-22fe-4881-e053-2a91aa0a70ce2026-01-08WarningsExact identifier
unii: 339NCG44TV
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Biting Insect Mix 1002BITING INSECT MIXProfessional Complementary Health Formulas87ea016e-1b53-41a4-87c0-8a84995fd1c32026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Hyperhidrosis Drops 2144HYPERHIDROSIS DROPSProfessional Complementary Health Formulasbca49d5e-6ade-41d5-82f5-1551936d0a3b2026-01-08WarningsExact identifier
unii: Q40Q9N063P
Tap Water Detox 6018TAP WATER DETOXProfessional Complementary Health Formulasae0bca6a-118e-40a2-9108-14fc415524442026-01-08WarningsExact identifier
unii: 339NCG44TV
Airborne 1025AIRBORNEProfessional Complementary Health Formulas98c70c98-a8a6-4cc2-8a43-3e293941a3612026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Poison Ivy/Oak 1013POISON IVY/OAKProfessional Complementary Health Formulasa75d1f82-703b-48a3-a6a2-a7ed1cdde0af2026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Northwest Regional 1019NORTHWEST REGIONALProfessional Complementary Health Formulas4dccc9f6-4d9e-4eec-b031-1fccdddb3d032026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Nightshade Mix 1011NIGHTSHADE MIXProfessional Complementary Health Formulas8ccfb31a-1337-442a-b79c-1be94bb3da2a2026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Pets 1001PETSProfessional Complementary Health Formulascdc1913b-bd3f-4732-b1bf-0737480a7a932026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Southwest Regional 1020SOUTHWEST REGIONALProfessional Complementary Health Formulasaef52f46-bae8-4e1c-9ac2-067ab8d7369f2026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Dairy Mix 1004DAIRY MIXProfessional Complementary Health Formulasd77ee02b-faf4-4af5-bf51-aeb41d99f3ff2026-01-08WarningsExact identifier
unii: K0U68Q2TXA
Northeast Regional 1021NORTHEAST REGIONALProfessional Complementary Health Formulas5f95ec6a-0b1e-4c14-91b5-b8332af3efdb2026-01-08WarningsExact identifier
unii: K0U68Q2TXA

Reported adverse events (FAERS/openFDA)#

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