FDA.reportPublic FDA data

NDC 63629-8666-01 - Hydrocortisone

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
63629-8666
Requested NDC
63629-8666-01
Package NDCs from labels
63629-8666-1, 63629-8666-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone - Bryant Ranch PrepackBryant Ranch Prepack2024-08-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8666-1Hydrocortisone1 in 1 CARTONCREAM1104
63629-8666-1Hydrocortisone20 g in 1 TUBECREAM20104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8666HYDROCORTISONE CREAM [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20240823_84c95149-9064-4b4d-a7d0-93dfefca1370.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8666-1GM - Gram63629-86661c842008-17c5-4536-a446-17f18dee888f12023-08-08

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 38 · 745 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydralynHYDRALYNOncora Pharma, LLC835f0335-0215-4955-9099-b601604916952026-08-12Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONESolco Healthcare LLC04f112e5-ec88-46c8-b675-8b4e38a86ab42026-08-11Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsExact identifier
unii: WI4X0X7BPJ
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsExact identifier
unii: WI4X0X7BPJ
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic SuspensionNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTICPreferred Pharmaceuticals, Inc.5f17fae0-c6ea-452e-b84f-066caf2a95fc2026-08-04Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEPreferred Pharmaceuticals, Inc.f8dc2b6f-daf3-4a3a-b31f-b97e2f152eae2026-08-04Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEPreferred Pharmaceuticals Inc.e7c7d23c-25f0-41ea-a563-59f46882d9fc2026-08-04Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack484fe5e4-a058-49c0-a382-c8fc3e20c3b22026-08-04WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEREMEDYREPACK INC.f0e66726-946b-4f63-b457-2851dc69e6b42026-08-03Adverse reactionsExact identifier
application number: ANDA085025
rxcui: 310891
unii: WI4X0X7BPJ
Cortizone 10 Itch Relief Massaging RollerballHYDROCORTISONEChattem, Inc.1e27682c-f856-41f1-9935-37540960a4c72026-07-31WarningsExact identifier
unii: WI4X0X7BPJ
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
1% Hydrocortisone Anti-itch1% HYDROCORTISONE ANTI-ITCHALAINA HEALTHCARE PRIVATE LIMITEDb8416467-55f7-4e5f-a5cb-3abd3e2bb5772026-07-27WarningsExact identifier
unii: WI4X0X7BPJ
hydrocortisoneHYDROCORTISONEEywa Pharma Incb3f06d10-2f01-428c-88a4-505c61c87ce82026-07-25Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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