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 5 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EPIFOAMPRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATEViatris Specialty LLCb22b8b41-2f1e-11e4-8c21-0800200c9a662024-02-15Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals7a664a34-19fd-4a7b-ab4d-11299b32999e2024-01-30Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticalsfd6343a9-15a6-4894-b51f-122e4d6dbe792024-01-30Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals951862db-3a73-4d25-9d5b-e4111833f43b2024-01-30Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals6aa284d6-0212-4fb5-809d-c721aa6fe2ba2024-01-30Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATEUnifirst First Aid Corporationbd216f5d-f304-7d8d-e053-2a95a90aa9ce2024-01-17WarningsExact identifier
unii: 3X7931PO74
Green Guard Hydrocortisone 1%HYDROCORTISONEUnifirst First Aid Corporationbd348e2a-57b1-3f17-e053-2a95a90a8bdc2024-01-17WarningsExact identifier
unii: 3X7931PO74
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cfde0-c463-e9b5-e053-2a95a90a19242024-01-15WarningsExact identifier
unii: 3X7931PO74
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cce4b-c70a-1b2d-e053-2995a90aa4aa2024-01-15WarningsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEBryant Ranch Prepack172e225e-9a00-4a5c-b209-8f3fa6b58d0f2024-01-11Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEBryant Ranch Prepack653fa10e-ab54-4b14-9ffa-8fd95b5e10402024-01-11Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
Poli-AHYDROCORTISONE ACETATESato Pharmaceutical Co., Ltd.e27a3840-d9de-4bd0-ad75-8a151bd12b832023-11-28WarningsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATECosette Pharmaceuticals, Inc.c84ab549-1d5c-4646-a041-6cb571812ad82023-11-23Adverse reactionsExact identifier
unii: 3X7931PO74
ANUCORT-HCHYDROCORTISONE ACETATECosette Pharmaceuticals, Inc.f0f5a107-1236-8e1a-815d-dec8007c2bc92023-11-22Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesd6523993-d781-cdbc-e053-2a95a90af1912023-11-17WarningsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEBentlin Products LLC4346351c-8e11-46ae-b428-98d17f55beb92023-10-30WarningsExact identifier
unii: 3X7931PO74
HYDROCORTISONE ACETATEHYDROCORTISONE ACETATENivagen Pharmaceuticals, Inc.7743779d-1e42-4b23-bde5-0d77fe95bb2b2023-08-28Adverse reactionsExact identifier
ndc (package): 75834-147-12
ndc (package): 75834-147-06
ndc (package): 75834-147-24
ndc (product): 75834-147
ndc11 (package): 75834014706
rxcui: 1291082
spl id: fe395d7c-ccaa-4f49-a902-70a9f6fce571
spl set id: 7743779d-1e42-4b23-bde5-0d77fe95bb2b
unii: 3X7931PO74
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack0c28458a-cc56-4eea-89aa-d60659bd95682023-08-17Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack2f036f41-93b9-4653-b24b-6fadf6fae4e42023-07-18Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepackc79ca385-5fff-4d86-a8b2-098d3e0aa8fa2023-07-18Adverse reactionsExact identifier
unii: 3X7931PO74

Reported adverse events (FAERS/openFDA)#

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