FDA.reportPublic FDA data

Application 085981

Type
ANDA
Sponsor
X GEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCORTISONE ACETATEHYDROCORTISONE ACETATEPOWDER;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
A085981-001HYDROCORTISONE ACETATEHYDROCORTISONE ACETATE100%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 22:54:322026-06A085981-001HYDROCORTISONE ACETATE100%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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone AcetateHYDROCORTISONE ACETATEAARNA USA INC.4f9709ed-4818-3d3b-e063-6394a90a0d042026-04-16Adverse reactionsName fallback
brand name: Hydrocortisone Acetate
generic name: HYDROCORTISONE ACETATE
Hydrocortisone AcetateHYDROCORTISONE ACETATEAvPAKd13b0bea-4c7b-4ee4-aab1-aca8cdcea7fd2026-01-08Adverse reactionsName fallback
brand name: Hydrocortisone Acetate
generic name: HYDROCORTISONE ACETATE
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inc4a543f90-d43c-4487-b27e-f43394c6320d2026-01-04WarningsName fallback
generic name: HYDROCORTISONE ACETATE
Hemmorex-HCHYDROCORTISONE ACETATELaser Pharmaceuticals, LLCd625764a-6171-4802-9bc0-95e5785b8b7d2026-01-01Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE ACETATE
MEDI FIRST PLUSHYDROCORTISONE ACETATEOrazen Inc5781124a-60f4-4a64-80b7-ce5f28d495b52025-12-12WarningsName fallback
generic name: HYDROCORTISONE ACETATE
MEDI-FIRSTHYDROCORTISONE ACETATEOrazen Incaeffd85c-58a7-4d64-bf94-977b6fbbe7132025-12-12WarningsName fallback
generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate Antipruritic (Anti-Itch)HYDROCORTISONE ACETATESun Pharmaceutical Industries, Inc.9f0b09e7-6cfd-4fd6-8631-67799edf4e082025-12-02WarningsName fallback
generic name: HYDROCORTISONE ACETATE
Hydrocortisone AcetateHYDROCORTISONE ACETATEMarlex Pharmaceuticals, Inc.e60473f7-fd00-a477-e053-2a95a90ad4dd2025-11-13Adverse reactionsName fallback
brand name: Hydrocortisone Acetate
generic name: HYDROCORTISONE ACETATE
Hydrocortisone AcetateHYDROCORTISONE ACETATEMajor Pharmaceuticals1281a82d-df00-4421-9c0d-951f8f9a94222025-08-05Adverse reactionsName fallback
brand name: Hydrocortisone Acetate
generic name: HYDROCORTISONE ACETATE
HydrocortisoneHYDROCORTISONE ACETATERite Aid Corporationcb6e0bed-2ea1-49d2-89e7-2554e7565b742025-07-11WarningsName fallback
generic name: HYDROCORTISONE ACETATE
HydrocortisoneHYDROCORTISONE ACETATEWalgreen Companybff322f1-59c3-41e0-8685-fcfe52bf4b422025-07-10WarningsName fallback
generic name: HYDROCORTISONE ACETATE
procureHYDROCORTISONE ACETATETWIN MED, LLC2670c9c4-66ad-40e8-a08a-582b160de39d2025-06-20WarningsName fallback
generic name: HYDROCORTISONE ACETATE
HYDROCORTISONE ACETATEHYDROCORTISONE ACETATEGolden State Medical Supply, Inc.fe42cde7-b3ac-2014-e053-6394a90a0f672025-02-24Adverse reactionsName fallback
brand name: HYDROCORTISONE ACETATE
generic name: HYDROCORTISONE ACETATE
Hemmorex-HCHYDROCORTISONE ACETATELaser Pharmaceuticals, LLCdb67f724-c78c-4280-9c2e-6abbaeaef42d2025-01-23Adverse reactionsName fallback
generic name: HYDROCORTISONE ACETATE
Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin FormulaHYDROCORTISONE ACETATECombe Incorporated9b69fa24-02dd-43e4-a81f-9a37968d70992024-12-12WarningsName fallback
generic name: HYDROCORTISONE ACETATE
Hydrocortisone AcetateHYDROCORTISONE ACETATEWestminster Pharmaceuticals, LLC3a29006f-9124-45e7-84a2-48f08bbb5f9c2024-12-04Adverse reactionsName fallback
brand name: Hydrocortisone Acetate
generic name: HYDROCORTISONE ACETATE
ProctocortHYDROCORTISONE ACETATESalix Pharmaceuticals, Inca2e1222a-ab91-4382-a210-7dfdd6de14072024-09-17Adverse reactionsName fallback
generic name: HYDROCORTISONE ACETATE
Anti-Itch Vulva Cream 1 Hydrocortisone AcetateHYDROCORTISONE ACETATEThe Honey Pot Company LLC6f32b536-6ebf-49a8-abb6-2a1daae2f6d72024-08-01WarningsName fallback
generic name: HYDROCORTISONE ACETATE
Hydrocortisone AcetateHYDROCORTISONE ACETATENuCare Pharmaceuticals,Inc.af1142eb-553e-7686-e053-2a95a90a0f9a2024-07-17Adverse reactionsName fallback
brand name: Hydrocortisone Acetate
generic name: HYDROCORTISONE ACETATE
Anusol HCHYDROCORTISONE ACETATESalix Pharmaceuticals, Inca562f3d7-2692-4357-aade-ae50afcbfddd2024-07-01Adverse reactionsName fallback
generic name: HYDROCORTISONE ACETATE