FDA.reportPublic FDA data

hydrocortisone acetate 30 MG Rectal Suppository

RxCUI
1291085
RxNorm name
hydrocortisone acetate 30 MG Rectal Suppository
Display name
Hydrocortisone (Rectal)
Full name
hydrocortisone acetate 30 MG Rectal Suppository
Term type
SCD
Status
Active
Strength
30 mg
Dose form
Suppository
Route
Rectal
Updated
2026-10-21 07:28:47

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
062012
Active start
062012
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
hydrocortisone acetate30 MG / 1 EACHhydrocortisonehydrocortisone acetate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Rectal Suppository316978

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
hydrocortisone5492

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRhydrocortisone acetate 30 MG Rectal Suppository1NAMES
RxNorm Namehydrocortisone acetate 30 MG Rectal Suppository1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
8 linked values
8CODES
RxCUI12910851CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0574-7093-120574-7093Hydrocortisone Acetate HYDROCORTISONE ACETATEPadagis US LLC
0713-0493-120713-0493Hydrocortisone Acetate HYDROCORTISONE ACETATECosette Pharmaceuticals, Inc.
16571-164-2116571-164Hydrocortisone Acetate Hydrocortisone AcetateRising Pharma Holdings, Inc.
24689-103-0124689-103Hydrocortisone Acetate Hydrocortisone AcetateAPNAR PHARMA LP
39328-129-1239328-129Hydrocortisone Acetate Hydrocortisone AcetatePatrin Pharma Inc.
63629-2531-163629-2531Hydrocortisone Acetate HYDROCORTISONE ACETATEBryant Ranch Prepack
69367-260-1269367-260Hydrocortisone Acetate Hydrocortisone AcetateWestminster Pharmaceuticals, LLC
82568-0160-182568-0160Hydrocortisone Acetate Hydrocortisone AcetateAARNA USA INC.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 26 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00574709312rxnav_ndcsyes
00713049312rxnav_ndcsyes
16571016421rxnav_ndcsyes
24689010301rxnav_ndcsyes
39328012912rxnav_ndcsyes
42494030212rxnav_ndcsyes
42494034212rxnav_ndcsyes
63629199601rxnav_ndcsyes
63629253101rxnav_ndcsyes
69367026012rxnav_ndcsyes
71321060312rxnav_ndcsyes
82568016001rxnav_ndcsyes
00245011212rxnav_historical_indirect
00245011224rxnav_historical_indirect
00254813606rxnav_historical_indirect
00254813611rxnav_historical_indirect
00254813615rxnav_historical_indirect
00254840106rxnav_historical_indirect
00254840115rxnav_historical_indirect
00603813611rxnav_historical_indirect
00603813618rxnav_historical_indirect
21695073112rxnav_historical_indirect
61570002512rxnav_historical_indirect
61570002525rxnav_historical_indirect
65649051112rxnav_historical_indirect
65649051124rxnav_historical_indirect

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone AcetateHYDROCORTISONE ACETATEAARNA USA INC.4f9709ed-4818-3d3b-e063-6394a90a0d042026-04-16Adverse reactionsExact identifier
ndc (package): 82568-0160-1
ndc (product): 82568-0160
ndc11 (package): 82568016001
rxcui: 1291085
Hemmorex-HCHYDROCORTISONE ACETATELaser Pharmaceuticals, LLCd625764a-6171-4802-9bc0-95e5785b8b7d2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 1291085
Hydrocortisone AcetateHYDROCORTISONE ACETATEWestminster Pharmaceuticals, LLC3a29006f-9124-45e7-84a2-48f08bbb5f9c2024-12-04Adverse reactionsExact identifier
ndc (package): 69367-260-12
ndc (product): 69367-260
ndc11 (package): 69367026012
rxcui: 1291085
ProctocortHYDROCORTISONE ACETATESalix Pharmaceuticals, Inca2e1222a-ab91-4382-a210-7dfdd6de14072024-09-17Adverse reactionsExact identifier
ndc11 (package): 65649051124
ndc11 (package): 65649051112
rxcui: 1291085
Hydrocortisone AcetateHYDROCORTISONE ACETATERising Pharma Holdings, Inc.de171b0a-3854-4aaa-889e-f2d999c0458c2024-02-20Adverse reactionsExact identifier
ndc (package): 16571-164-21
ndc (product): 16571-164
ndc11 (package): 16571016421
rxcui: 1291085
Hydrocortisone AcetateHYDROCORTISONE ACETATEBryant Ranch Prepack172e225e-9a00-4a5c-b209-8f3fa6b58d0f2024-01-11Adverse reactionsExact identifier
ndc (package): 63629-2531-1
ndc (product): 63629-2531
ndc11 (package): 63629253101
rxcui: 1291085
Hydrocortisone AcetateHYDROCORTISONE ACETATECosette Pharmaceuticals, Inc.c84ab549-1d5c-4646-a041-6cb571812ad82023-11-23Adverse reactionsExact identifier
ndc (package): 0713-0493-12
ndc (product): 0713-0493
ndc11 (package): 00713049312
rxcui: 1291085
Hydrocortisone AcetateHYDROCORTISONE ACETATEPadagis US LLC2fdb9940-6da8-49b0-a236-9817943f7a4b2022-05-31Adverse reactionsExact identifier
ndc (package): 0574-7093-12
ndc (product): 0574-7093
ndc11 (package): 00574709312
rxcui: 1291085
Hydrocortisone AcetateHYDROCORTISONE ACETATEAPNAR PHARMA LPcb60f2a6-8bab-c0f9-e053-2a95a90a422a2022-03-16Adverse reactionsExact identifier
ndc (package): 24689-103-01
ndc (product): 24689-103
ndc11 (package): 24689010301
rxcui: 1291085
Hydrocortisone AcetateHYDROCORTISONE ACETATEPatrin Pharma Inc.7c1d2c8c-26e2-432f-b983-505f259665a92021-12-22Adverse reactionsExact identifier
ndc (package): 39328-129-12
ndc (product): 39328-129
ndc11 (package): 39328012912
rxcui: 1291085

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 10 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
172e225e-9a00-4a5c-b209-8f3fa6b58d0fhydrocortisone acetate 30 MG Rectal Suppository [PSN] · hydrocortisone acetate 30 MG Rectal Suppository [SCD]2103Hydrocortisone Acetate Suppositories20240111
3a29006f-9124-45e7-84a2-48f08bbb5f9chydrocortisone acetate 30 MG Rectal Suppository [PSN] · hydrocortisone acetate 30 MG Rectal Suppository [SCD]210Hydrocortisone Acetate Suppositories 25mg and 30mg20241204
2fdb9940-6da8-49b0-a236-9817943f7a4bhydrocortisone acetate 30 MG Rectal Suppository [PSN] · hydrocortisone acetate 30 MG Rectal Suppository [SCD]27Hydrocortisone Acetate Suppositories20220531
d625764a-6171-4802-9bc0-95e5785b8b7dhydrocortisone acetate 30 MG Rectal Suppository [PSN] · hydrocortisone acetate 30 MG Rectal Suppository [SCD]24Hemmorex-HC20260101
a2e1222a-ab91-4382-a210-7dfdd6de1407hydrocortisone acetate 30 MG Rectal Suppository [PSN] · hydrocortisone acetate 30 MG Rectal Suppository [SCD]24PROCTOCORT® Hydrocortisone Acetate Rectal Suppositories, 30 mg Rx only20240917
de171b0a-3854-4aaa-889e-f2d999c0458chydrocortisone acetate 30 MG Rectal Suppository [PSN] · hydrocortisone acetate 30 MG Rectal Suppository [SCD]22Hydrocortisone Acetate Suppositories, 25 mg Hydrocortisone Acetate Suppositories, 30 mg For Rectal Administration Rx only20240220
c84ab549-1d5c-4646-a041-6cb571812ad8hydrocortisone acetate 30 MG Rectal Suppository [PSN] · hydrocortisone acetate 30 MG Rectal Suppository [SCD]22HYDROCORTISONE ACETATE, 30 mg Rectal Suppositories Rx only20231123
cb60f2a6-8bab-c0f9-e053-2a95a90a422ahydrocortisone acetate 30 MG Rectal Suppository [PSN] · hydrocortisone acetate 30 MG Rectal Suppository [SCD]22Hydrocortisone Acetate Suppositories20220316
4f9709ed-4818-3d3b-e063-6394a90a0d04hydrocortisone acetate 30 MG Rectal Suppository [PSN] · hydrocortisone acetate 30 MG Rectal Suppository [SCD]21Hydrocortisone Acetate Suppositories 25mg and 30mg20260416
7c1d2c8c-26e2-432f-b983-505f259665a9hydrocortisone acetate 30 MG Rectal Suppository [PSN] · hydrocortisone acetate 30 MG Rectal Suppository [SCD]21Hydrocortisone Acetate Suppositories20211222

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
4f9709ed-4818-3d3b-e063-6394a90a0d04Hydrocortisone Acetate Suppositories 25mg and 30mgAARNA USA INC.20260416
53b4cc7a-fbf5-4f6a-8d01-52a24d2071edHydrocortisone Acetate Suppositories, 30 mg For Rectal AdministrationCameron Pharmaceuticals, Limited Liability Company | MSH Pharma Inc.20250120
3a29006f-9124-45e7-84a2-48f08bbb5f9cHydrocortisone Acetate Suppositories 25mg and 30mgWestminster Pharmaceuticals, LLC20241204
3a29006f-9124-45e7-84a2-48f08bbb5f9cHydrocortisone Acetate Suppositories 25mg and 30mgWestminster Pharmaceuticals, LLC20241204
3a29006f-9124-45e7-84a2-48f08bbb5f9cHydrocortisone Acetate Suppositories 25mg and 30mgWestminster Pharmaceuticals, LLC | LGM Pharma Solutions20241204
a2e1222a-ab91-4382-a210-7dfdd6de1407PROCTOCORT® Hydrocortisone Acetate Rectal Suppositories, 30 mg Rx onlySalix Pharmaceuticals, Inc | Paddock Laboratories, LLC20240917
de171b0a-3854-4aaa-889e-f2d999c0458cHydrocortisone Acetate Suppositories, 25 mg Hydrocortisone Acetate Suppositories, 30 mg For Rectal Administration Rx onlyRising Pharma Holdings, Inc. | QUAGEN PHARMACEUTICALS LLC20240220
172e225e-9a00-4a5c-b209-8f3fa6b58d0fHydrocortisone Acetate SuppositoriesBryant Ranch Prepack20240111
c84ab549-1d5c-4646-a041-6cb571812ad8HYDROCORTISONE ACETATE, 30 mg Rectal Suppositories Rx onlyCosette Pharmaceuticals, Inc. | Cosette Pharmaceuticals NC Laboratories, LLC20231123
2fdb9940-6da8-49b0-a236-9817943f7a4bHydrocortisone Acetate SuppositoriesPadagis US LLC20220531
cb60f2a6-8bab-c0f9-e053-2a95a90a422aHydrocortisone Acetate SuppositoriesAPNAR PHARMA LP20220316
a078a41a-fdc7-4425-9801-939671920962Hydrocortisone Acetate Suppositories For Rectal AdministrationBrandywine Pharmaceuticals, Inc.20211230
7c1d2c8c-26e2-432f-b983-505f259665a9Hydrocortisone Acetate SuppositoriesPatrin Pharma Inc.20211222
31600f68-3da3-46c0-979c-05c0ca110b94Hydrocortisone Acetate Suppositories, 30 mg For Rectal Administration Rx onlyBryant Ranch Prepack20210413
54faa257-9a88-40bf-bf41-39d8d366d53aHydrocortisone Acetate Suppositories, 30 mg For Rectal Administration Rx onlyCameron Pharmaceuticals, LLC20170501
233c1cdd-ed8b-4513-a4fa-c1a544a26649National Council for Prescription Drug Programs20130213
70714f21-5a4a-4ed3-8cda-5c271bd2c594Hydrocortisone Acetate Suppositories 30 mgPaddock Laboratories, LLC20120817
90a6a4f5-7f23-4c1e-aad0-a270189f014cNational Council for Prescription Drug Programs20120724
3bb75bb7-0c8b-4e71-83a8-da9edbae349fNational Council for Prescription Drug Programs20120724
d98e8ba0-5d0d-4a1e-9907-953e7d1e45b7Hydrocortisone AcetateRebel Distributors Corp20110608

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS02BACorticosteroidsATC1-4hydrocortisone
ATCC05AACorticosteroidsATC1-4hydrocortisone
ATCA07EACorticosteroids acting locallyATC1-4hydrocortisone
ATCA01ACCorticosteroids for local oral treatmentATC1-4hydrocortisone
ATCS01BACorticosteroids, plainATC1-4hydrocortisone
ATCD07AACorticosteroids, weak (group I)ATC1-4hydrocortisone
ATCD07XACorticosteroids, weak, other combinationsATC1-4hydrocortisone
ATCS01CBCorticosteroids/antiinfectives/mydriatics in combinationATC1-4hydrocortisone
ATCH02ABGlucocorticoidsATC1-4hydrocortisone
FDASPLN0000175576CorticosteroidEPChas_epchydrocortisone
MEDRTD006854HydrocortisoneCHEMhas_ingredienthydrocortisone
MEDRTD006854HydrocortisoneCHEMhas_ingredienthydrocortisone acetate
MEDRTD000312Adrenal Hyperplasia, CongenitalDISEASEmay_treathydrocortisone acetate
MEDRTD000312Adrenal Hyperplasia, CongenitalDISEASEmay_treathydrocortisone
MEDRTD000309Adrenal InsufficiencyDISEASEmay_treathydrocortisone acetate
MEDRTD000309Adrenal InsufficiencyDISEASEmay_treathydrocortisone
MEDRTD003093Colitis, UlcerativeDISEASEmay_treathydrocortisone acetate
MEDRTD003093Colitis, UlcerativeDISEASEmay_treathydrocortisone
MEDRTD003877Dermatitis, ContactDISEASEmay_treathydrocortisone acetate
MEDRTD003877Dermatitis, ContactDISEASEmay_treathydrocortisone
MEDRTD003881DermatomycosesDISEASEci_withhydrocortisone acetate
MEDRTD003881DermatomycosesDISEASEci_withhydrocortisone
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrocortisone acetate
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrocortisone
MEDRTD005148Facial DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD005148Facial DermatosesDISEASEmay_treathydrocortisone
MEDRTD005533Foot DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD005533Foot DermatosesDISEASEmay_treathydrocortisone
MEDRTD006229Hand DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD006229Hand DermatosesDISEASEmay_treathydrocortisone
MEDRTD006484HemorrhoidsDISEASEmay_treathydrocortisone acetate
MEDRTD006484HemorrhoidsDISEASEmay_treathydrocortisone
MEDRTD007249InflammationDISEASEmay_treathydrocortisone acetate
MEDRTD007249InflammationDISEASEmay_treathydrocortisone
MEDRTD007868Leg DermatosesDISEASEmay_treathydrocortisone
MEDRTD007868Leg DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD011538Pruritus AniDISEASEmay_treathydrocortisone acetate
MEDRTD011538Pruritus AniDISEASEmay_treathydrocortisone
MEDRTD012216Rheumatic DiseasesDISEASEmay_treathydrocortisone acetate
MEDRTD012216Rheumatic DiseasesDISEASEmay_treathydrocortisone
MEDRTD012536Scalp DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD012536Scalp DermatosesDISEASEmay_treathydrocortisone
MEDRTD012769ShockDISEASEmay_treathydrocortisone
MEDRTD012769ShockDISEASEmay_treathydrocortisone acetate
MEDRTD012876Skin Diseases, ParasiticDISEASEci_withhydrocortisone
MEDRTD012876Skin Diseases, ParasiticDISEASEci_withhydrocortisone acetate
MEDRTD017193Skin Diseases, ViralDISEASEci_withhydrocortisone
MEDRTD017193Skin Diseases, ViralDISEASEci_withhydrocortisone acetate
MEDRTD013224Status AsthmaticusDISEASEmay_treathydrocortisone acetate
MEDRTD013224Status AsthmaticusDISEASEmay_treathydrocortisone
MEDRTD014382Tuberculosis, CutaneousDISEASEci_withhydrocortisone
MEDRTD014382Tuberculosis, CutaneousDISEASEci_withhydrocortisone acetate
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moahydrocortisone acetate
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moahydrocortisone
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moahydrocortisone
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moahydrocortisone acetate
MEDRTN0000008327Carbohydrate Metabolism AlterationPEhas_pehydrocortisone acetate
MEDRTN0000008327Carbohydrate Metabolism AlterationPEhas_pehydrocortisone
MEDRTN0000010253Decreased Capillary PermeabilityPEhas_pehydrocortisone acetate
MEDRTN0000010253Decreased Capillary PermeabilityPEhas_pehydrocortisone
MEDRTN0000010248Decreased Fibroblast MigrationPEhas_pehydrocortisone acetate
MEDRTN0000010248Decreased Fibroblast MigrationPEhas_pehydrocortisone
MEDRTN0000008645Decreased Glucocorticoid SecretionPEhas_pehydrocortisone acetate
MEDRTN0000008645Decreased Glucocorticoid SecretionPEhas_pehydrocortisone
MEDRTN0000008681Decreased Leukotriene ActivityPEhas_pehydrocortisone
MEDRTN0000008681Decreased Leukotriene ActivityPEhas_pehydrocortisone acetate
MEDRTN0000008700Decreased Lysosomal FunctionPEhas_pehydrocortisone acetate
MEDRTN0000008700Decreased Lysosomal FunctionPEhas_pehydrocortisone
MEDRTN0000010246Decreased Polymorphonuclear Leukocyte MigrationPEhas_pehydrocortisone acetate
MEDRTN0000010246Decreased Polymorphonuclear Leukocyte MigrationPEhas_pehydrocortisone
MEDRTN0000008834Decreased Prostaglandin ActivityPEhas_pehydrocortisone acetate
MEDRTN0000008834Decreased Prostaglandin ActivityPEhas_pehydrocortisone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pehydrocortisone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pehydrocortisone acetate
MEDRTN0000009004Decreased Thromboxane ActivityPEhas_pehydrocortisone
MEDRTN0000009004Decreased Thromboxane ActivityPEhas_pehydrocortisone acetate
MEDRTN0000009739Lipid Metabolism AlterationPEhas_pehydrocortisone
MEDRTN0000009739Lipid Metabolism AlterationPEhas_pehydrocortisone acetate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH30 MG (expressed as hydrocortisone acetate)
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESVUID4014154
NAMESPrescribable Synonymhydrocortisone acetate 30 MG Rectal Suppository
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File