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 2 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thompson Hydrocortisone 1%HYDROCORTISONEThompsonf8740314-7e1f-815e-e053-6294a90a6eae2025-12-05WarningsExact identifier
unii: 3X7931PO74
Hydrocortisone Acetate Antipruritic (Anti-Itch)HYDROCORTISONE ACETATESun Pharmaceutical Industries, Inc.9f0b09e7-6cfd-4fd6-8631-67799edf4e082025-12-02WarningsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEMarlex Pharmaceuticals, Inc.e60473f7-fd00-a477-e053-2a95a90ad4dd2025-11-13Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.fecf8380-3bb5-11e5-98c5-0002a5d5c51b2025-11-08Adverse reactionsExact identifier
unii: 3X7931PO74
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.1469733e-1723-4b8c-be33-ed8dfafd65e22025-11-08Adverse reactionsExact identifier
unii: 3X7931PO74
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.f207bdff-2f41-4eee-818e-198b6462863e2025-11-08Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepacka6a5e63c-29ca-4d30-b8b6-b3bd18a25c382025-10-24Adverse reactionsExact identifier
unii: 3X7931PO74
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATE 1%Unifirst First Aid Corporationf2b46d69-1c21-5ae9-e053-2a95a90a60a92025-10-24WarningsExact identifier
unii: 3X7931PO74
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLBryant Ranch Prepackd59665d7-a0f4-4318-b452-171c54ed156c2025-10-24Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepackf219b99e-9b73-4021-9d4c-8c7b0f129c932025-10-24Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack26c380c0-5b11-4b11-a5a6-823510b0fd0f2025-10-24Adverse reactionsExact identifier
unii: 3X7931PO74
Vanicream HC Anti-ItchHYDROCORTISONEPharmaceutical Specialties, Inc.28b06507-27a5-2cb1-e054-00144ff8d46c2025-10-14WarningsExact identifier
unii: 3X7931PO74
HYDROCORTISONEHYDROCORTISONEHF Acquisition Co LLC, DBA HealthFirst3ba6a5ec-fda2-b2a6-e063-6294a90ac9b62025-08-05WarningsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEMajor Pharmaceuticals1281a82d-df00-4421-9c0d-951f8f9a94222025-08-05Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
Hydrocortisone Acetate CreamHYDROCORTISONE ACETATE CREAMAllegis Holdings LLC3b008546-afa5-fe5a-e063-6394a90adb3b2025-07-28Adverse reactionsExact identifier
unii: 3X7931PO74
HydrocortisoneHYDROCORTISONE ACETATERite Aid Corporationcb6e0bed-2ea1-49d2-89e7-2554e7565b742025-07-11WarningsExact identifier
unii: 3X7931PO74
HydrocortisoneHYDROCORTISONE ACETATEWalgreen Companybff322f1-59c3-41e0-8685-fcfe52bf4b422025-07-10WarningsExact identifier
unii: 3X7931PO74
Pramosone CreamHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.6a9fb75b-a2f7-4eca-8dce-d7eb5c1224762025-06-30Adverse reactionsExact identifier
unii: 3X7931PO74
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.39618fc5-87a8-47bc-93fc-cb97b8f663c82025-06-24Adverse reactionsExact identifier
unii: 3X7931PO74
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.56568e1f-974b-4750-b560-d93eb5e0e83f2025-06-09Adverse reactionsExact identifier
unii: 3X7931PO74

Reported adverse events (FAERS/openFDA)#

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