FDA.reportPublic FDA data

NDC 75834-147-06 - HYDROCORTISONE ACETATE

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
75834-147
Requested NDC
75834-147-06
Package NDCs from labels
75834-147-06, 75834-147-12, 75834-147-24
Manufacturer
Nivagen Pharmaceuticals, Inc.
Effective date
2023-08-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone Acetate, 25 mg Rectal SuppositoriesNivagen Pharmaceuticals, Inc.2023-08-28HUMAN PRESCRIPTION DRUG LABEL
HYDROCORTISONE ACETATE - A-S Medication SolutionsA-S Medication Solutions2021-09-29HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
75834-147-122023-08-28Hydrocortisone Acetate, 25 mg Rectal Suppositories
75834-147-242023-08-28Hydrocortisone Acetate, 25 mg Rectal Suppositories
75834-147-122023-01-30Hydrocortisone Acetate, 25 mg Rectal Suppositories
75834-147-242023-01-30Hydrocortisone Acetate, 25 mg Rectal Suppositories
75834-147-122021-09-23Hydrocortisone Acetate, 25 mg Rectal Suppositories
75834-147-242021-09-23Hydrocortisone Acetate, 25 mg Rectal Suppositories
75834-147-122021-07-23Hydrocortisone Acetate, 25 mg Rectal Suppositories
75834-147-242021-07-23Hydrocortisone Acetate, 25 mg Rectal Suppositories

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-147-06HYDROCORTISONE ACETATE6 in 1 BLISTER PACKSUPPOSITORY64
75834-147-12HYDROCORTISONE ACETATE2 in 1 CARTONSUPPOSITORY24
75834-147-24HYDROCORTISONE ACETATE4 in 1 CARTONSUPPOSITORY44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-147HYDROCORTISONE ACETATE SUPPOSITORY [NIVAGEN PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20230829_7743779d-1e42-4b23-bde5-0d77fe95bb2b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-147-12EA - Each75834-147531486e6-0ff5-40d3-bc55-77f25d3e9c8712020-08-06
75834-147-24EA - Each75834-147b61d26d7-52bb-46d4-b3ba-6cca3630a48a12020-08-06

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 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATEWestminster Pharmaceuticals, LLC0cd1394d-e7b2-4e60-87ac-e12a0bda9d672024-11-21Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
LidocortLIDOCAINE HCL - HYDROCORTISONE ACETATEPureTek Corporationae49ddc6-26f0-7f92-e053-2995a90ab2f92024-11-11Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone Acetate, IodoquinolHYDROCORTISONE ACETATE, IODOQUINOLKMM Pharmaceuticals, LLCd9170a5e-730e-f7c7-e053-2995a90aa6bc2024-11-04Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
VytoneHYDROCORTISONE ACETATE, IODOQUINOLEckson Labs LLCdb751fea-59d7-314c-e053-2a95a90ae3822024-11-04Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incea656cf8-cad5-4fa5-82e7-daec77a0bb042024-10-07WarningsExact identifier
unii: 3X7931PO74
ProctocortHYDROCORTISONE ACETATESalix Pharmaceuticals, Inca2e1222a-ab91-4382-a210-7dfdd6de14072024-09-17Adverse reactionsExact identifier
unii: 3X7931PO74
LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE ACETATELIDOCAINE HYDROCHLORIDE, HYDROCORTISONE ACETATECintex Services, LLC21dee088-0fb0-ecd0-e063-6294a90a0e572024-09-17Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE ACETATELIDOCAINE HYDROCHLORIDE, HYDROCORTISONE ACETATECintex Services, LLC21dcb757-1f7c-a4ca-e063-6394a90a456d2024-09-17Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Anti-Itch Vulva Cream 1 Hydrocortisone AcetateHYDROCORTISONE ACETATEThe Honey Pot Company LLC6f32b536-6ebf-49a8-abb6-2a1daae2f6d72024-08-01WarningsExact identifier
unii: 3X7931PO74
Cortisporin TCCOLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE AND HYDROCORTISONE ACETATEEndo USA, Inc.9c6fc1c7-3350-42ae-b999-aca48e704bb12024-08-01Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATENuCare Pharmaceuticals,Inc.af1142eb-553e-7686-e053-2a95a90a0f9a2024-07-17Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
Anusol HCHYDROCORTISONE ACETATESalix Pharmaceuticals, Inca562f3d7-2692-4357-aade-ae50afcbfddd2024-07-01Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
astoneaHYDROCORTISONEASTONEA LABS PRIVATE LIMITEDde09e859-c5fd-0cc5-e053-2a95a90a147e2024-06-25WarningsExact identifier
unii: 3X7931PO74
Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent CreamLIDOCAINE HCL, HYDROCORTISONE ACETATEPureTek Corporation1a01b416-2ca5-c7fa-e063-6394a90a341b2024-06-03Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
CortifoamHYDROCORTISONE ACETATEViatris Specialty LLC0093b694-9fcb-46ae-b1ab-7d0fa204c6c82024-05-15Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
HYDROCORTISONEHYDROCORTISONE ACETATEJHK Inc dba American Safety & First Aid64adc8d0-7ca4-4c1a-813f-f1df47e916f22024-04-25WarningsExact identifier
unii: 3X7931PO74
Lidotral 5 Percent and Hydrocortisone 1 Percent with Peptides and ArnicaLIDOCAINE HCL 5 % , HYDROCORTISONE ACETATE 1%PureTek Corporation0d871371-91ca-9ad7-e063-6294a90a59072024-03-15Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Walgreens Eczema ReliefHYDROCORTISONE ACETATEWalgreen Co.4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c2024-02-28WarningsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATERising Pharma Holdings, Inc.de171b0a-3854-4aaa-889e-f2d999c0458c2024-02-20Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
HYDROCORTISONEHYDROCORTISONE ACETATEHART Health779f945f-ab69-40de-8d86-ab76debc5c7c2024-02-16WarningsExact identifier
unii: 3X7931PO74

Reported adverse events (FAERS/openFDA)#

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