FDA.reportPublic FDA data

Application 085982

Type
ANDA
Sponsor
X GEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDRO-RXHYDROCORTISONEPOWDER;FOR RX COMPOUNDING100%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085982-001HYDRO-RXHYDROCORTISONE100%POWDER / FOR RX COMPOUNDINGApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A085982-001HYDRO-RX100%POWDER / FOR RX COMPOUNDINGApproved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 19 · 368 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydrocortisoneHYDROCORTISONEEywa Pharma Incb3f06d10-2f01-428c-88a4-505c61c87ce82026-07-25Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsName fallback
generic name: HYDROCORTISONE
Barmicil PlusHYDROCORTISONEOPMX LLC5763b4de-06f2-7b19-e063-6294a90ad0682026-07-24WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCdaad9a1e-98d2-4ce7-9d97-ac5d81905abb2026-07-22WarningsName fallback
generic name: HYDROCORTISONE
LYEON Anti-itch CreamHYDROCORTISONEGuangzhou Xinhongda Trading Service Co., Ltd.56b773ce-167f-7873-e063-6394a90a98162026-07-16WarningsName fallback
generic name: HYDROCORTISONE
Barmicil PlusHYDROCORTISONEOPMX LLC5698207f-9223-f3a6-e063-6294a90a8ab62026-07-14WarningsName fallback
generic name: HYDROCORTISONE
Quadriderm NFHYDROCORTISONEOPMX LLC5643f850-e0d4-d8d8-e063-6294a90a42602026-07-10WarningsName fallback
generic name: HYDROCORTISONE
Drs. Hydrocortisone Aloe VeraHYDROCORTISONEOL PHARMA TECH,LLC0df06415-5d32-7ef8-e063-6294a90a6e5a2026-07-09WarningsName fallback
generic name: HYDROCORTISONE
Ala-ScalpHYDROCORTISONEDerm Ventures LLC61498a40-3b3c-4066-89c8-d99686e2d6382026-07-08Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
DIPROSPANHYDROCORTISONEOPMX LLC55fa9ecb-b843-5748-e063-6294a90a2d532026-07-06WarningsName fallback
generic name: HYDROCORTISONE
CVS No Mess CortisoneHYDROCORTISONENatural Essentials, Inc.558c94ec-95f1-eb98-e063-6394a90a1e722026-07-01WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEEncube Ethicals, Inc.11e120e2-a1ca-477c-b474-bcbb726567052026-06-26Adverse reactionsName fallback
generic name: HYDROCORTISONE
Medi-First Hydrocortisone 1 % Anti-Itch CreamHYDROCORTISONEUnifirst First Aid Corporation49f04e5d-746d-cbe9-e063-6294a90a7e882026-06-16WarningsName fallback
generic name: HYDROCORTISONE
HydroxymHYDROCORTISONEPureTek Corporationfebffc84-e65e-e811-e053-6294a90a0ad12026-06-15Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
Hydrocortisone 1% Anti-ItchCreamHYDROCORTISONEAcme United Corporation5425fc2b-4f25-3e64-e063-6394a90aff492026-06-13WarningsName fallback
generic name: HYDROCORTISONE
good sense anti itchHYDROCORTISONEPreferred Pharmaceuticals Inc.e51047da-8e17-4dd7-be3c-54820a7485f22026-06-09WarningsName fallback
generic name: HYDROCORTISONE
Walgreens Scalp Itch ReliefHYDROCORTISONEWalgreens34952272-1f9e-c642-e063-6394a90ae2bd2026-05-29WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEMylan Pharmaceuticals Inc.bc751403-94f2-4f9d-b533-cf6186a40ceb2026-05-25Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEBryant Ranch Prepack04758c46-0ca4-4852-acdc-1f8553ce2e6e2026-05-21Adverse reactionsName fallback
generic name: HYDROCORTISONE