FDA.reportPublic FDA data

NDC 72056-010-06 - 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
72056-010
Requested NDC
72056-010-06
Package NDCs from labels
72056-010-06, 72056-010-12, 72056-010-24
Manufacturer
Syntenza Pharmaceuticals LLC
Effective date
2018-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDROCORTISONE ACETATE - Syntenza Pharmaceuticals LLCSyntenza Pharmaceuticals LLC2018-07-18HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72056-010-122021-07-23C16284748780-1c7ccaba7-1263-fd44-e053-dadaa90aa01bHydrocortisone Acetate, 25 mg Rectal Suppositories
72056-010-242021-07-23C16284748780-1c7ccaba7-1263-fd44-e053-dadaa90aa01bHydrocortisone Acetate, 25 mg Rectal Suppositories

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72056-010-06HYDROCORTISONE ACETATE6 in 1 BLISTER PACKSUPPOSITORY62
72056-010-12HYDROCORTISONE ACETATE2 in 1 CARTONSUPPOSITORY22
72056-010-24HYDROCORTISONE ACETATE4 in 1 CARTONSUPPOSITORY42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72056-010HYDROCORTISONE ACETATE SUPPOSITORY [SYNTENZA PHARMACEUTICALS LLC]2Legacy NDC, 3 package rows20180730_883ff13e-1717-402d-8410-79a5e72550eb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72056-010-06EA - Each72056-0104025cf07-5b86-45ba-b2b3-93d38b03881912019-05-02
72056-010-12EA - Each72056-01051e68992-5119-44db-96c9-8317872e08fe12019-02-13
72056-010-24EA - Each72056-0108742491c-8f05-40e8-b6d1-733d4a0072a612019-02-13

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
Hydrocortisone AcetateHYDROCORTISONE ACETATEProficient Rx LP43ed7a9a-0aaf-4987-8367-e2490d1b84482020-05-07Adverse reactionsExact identifier
rxcui: 1291082
unii: 3X7931PO74
693d2a64-1f57-4b41-a541-ea488d0050e2883ff13e-1717-402d-8410-79a5e72550eb2018-07-18Adverse reactionsExact identifier
spl id: 693d2a64-1f57-4b41-a541-ea488d0050e2
spl set id: 883ff13e-1717-402d-8410-79a5e72550eb

Reported adverse events (FAERS/openFDA)#

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