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 6 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack79fae74b-bef2-4e13-a2e9-da68747951eb2023-07-18Adverse reactionsExact identifier
unii: 3X7931PO74
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLBryant Ranch Prepack2c74c1c8-91c7-4468-9b1a-7217834311962023-07-18Adverse reactionsExact identifier
unii: 3X7931PO74
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLBryant Ranch Prepack1436a6cb-5fa1-41a6-87af-dfbaf0ab2e5b2023-07-18Adverse reactionsExact identifier
unii: 3X7931PO74
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack3c5e1833-9908-4e4f-bdf2-7a28c14a585c2023-07-18Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEQUAGEN PHARMACEUTICALS LLC60dce400-1138-4781-b621-1774c0dbb64a2023-05-17Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEA-S Medication Solutions03321951-e338-4955-8622-0f5ea29c6cd92023-01-18Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
Radiaura Skin RecoveryLIDOCAINE HCL - HYDROCORTISONE ACETATEPureTek Corporationc9502692-674d-e53f-e053-2a95a90a74b32023-01-11Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd982f0862-2be8-4a65-8b61-8f3a95ab59512022-05-31Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd87a4c494-56f9-48f6-8592-d610c507a4fc2022-05-31Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEPadagis US LLC2fdb9940-6da8-49b0-a236-9817943f7a4b2022-05-31Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd9eea5875-d153-4bba-aee2-b1d1cd8b5e572022-05-31Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEAPNAR PHARMA LPcb60f2a6-8bab-c0f9-e053-2a95a90a422a2022-03-16Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEPatrin Pharma Inc.7c1d2c8c-26e2-432f-b983-505f259665a92021-12-22Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
e7a3211c-1218-47b6-9605-87784ae39abb92dda39b-f2b1-4a5c-95cb-8bd9010871ea2021-09-29Adverse reactionsExact identifier
spl id: e7a3211c-1218-47b6-9605-87784ae39abb
spl set id: 92dda39b-f2b1-4a5c-95cb-8bd9010871ea
Hydrocortisone AcetateHYDROCORTISONE ACETATEProficient Rx LP43ed7a9a-0aaf-4987-8367-e2490d1b84482020-05-07Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74

Reported adverse events (FAERS/openFDA)#

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