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 3 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.4c98a01e-ff11-45eb-8732-4bd9157969e82025-06-09Adverse reactionsExact identifier
unii: 3X7931PO74
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.ce3dd32c-1262-454e-aacb-880d54596dd32025-06-09Adverse reactionsExact identifier
unii: 3X7931PO74
SionBiotext HydrocortisoneHYDROCORTISONE ACETATE 1%Sion Biotext Medical Ltd35073eae-26fe-2bb5-e063-6294a90ab56a2025-05-13WarningsExact identifier
unii: 3X7931PO74
PROCORT1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAMWomens Choice Pharmaceuticals LLC9e899b72-a16e-4b55-93b5-ab5baec37d502025-04-28Adverse reactionsExact identifier
unii: 3X7931PO74
PROCTOFOAM HCPRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATEViatris Specialty LLC3831e931-ec0a-11e3-ac10-0800200c9a662025-04-15Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Post Treatment Repair CreamHYDROCORTISONEVege Labs LLC.302d4327-354b-a252-e063-6394a90a20b62025-03-12WarningsExact identifier
unii: 3X7931PO74
HYDROCORTISONE ACETATEHYDROCORTISONE ACETATEGolden State Medical Supply, Inc.fe42cde7-b3ac-2014-e053-6394a90a0f672025-02-24Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLBryant Ranch Prepackc95b9248-b4cc-43ce-acd2-fe20972f87ca2025-02-21Adverse reactionsExact identifier
unii: 3X7931PO74
ZCort UltraHYDROCORTISONE ACETATE 1%RxDino, LLCb68f8ada-58e8-e8e4-e053-2a95a90ab02d2025-01-29WarningsExact identifier
unii: 3X7931PO74
Lidocaine HCl - Hydrocortisone AcetateLIDOCAINE HCL AND HYDROCORTISONE ACETATEPureTek Corporation3a24be46-df26-477e-b909-04dd14d0a0142025-01-29Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
GerigentleHYDROCORTISONEGERI-GENTLE CORPORATION0adfa2f0-9758-5c54-e063-6294a90a461f2025-01-25WarningsExact identifier
unii: 3X7931PO74
Hemmorex-HCHYDROCORTISONE ACETATELaser Pharmaceuticals, LLCdb67f724-c78c-4280-9c2e-6abbaeaef42d2025-01-23Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
Lidocaine HCl - Hydrocortisone AcetateLIDOCAINE HCL AND HYDROCORTISONE ACETATEPureTek Corporationac6c6117-97cc-4b7a-a831-03fb23a54b702025-01-09Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Lidocaine HCl - Hydrocortisone Acetate with AloeLIDOCAINE HCL AND HYDROCORTISONE ACETATEPureTek Corporation454b8854-44d9-4cdb-a2e4-a782e36bed802025-01-09Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Lidocaine HCl - Hydrocortisone AcetateLIDOCAINE HCL AND HYDROCORTISONE ACETATEPureTek Corporation0db13203-e001-42fc-b3a2-7f189d171de32025-01-09Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Lidocaine HCl - Hydrocortisone AcetateLIDOCAINE HCL AND HYDROCORTISONE ACETATEPureTek Corporationf3b75de3-c9e6-4ecc-a286-5b279403911d2025-01-09Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLTRUPHARMA, LLCf531fa34-5711-42d0-82c4-3b9943cdcca92024-12-27Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepackdc836383-bf62-4240-857b-e98dbc68559b2024-12-26Adverse reactionsExact identifier
unii: 3X7931PO74
Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin FormulaHYDROCORTISONE ACETATECombe Incorporated9b69fa24-02dd-43e4-a81f-9a37968d70992024-12-12WarningsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEWestminster Pharmaceuticals, LLC3a29006f-9124-45e7-84a2-48f08bbb5f9c2024-12-04Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74

Reported adverse events (FAERS/openFDA)#

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