FDA.reportPublic FDA data

Application 040761

Type
ANDA
Sponsor
VINTAGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCORTISONEHYDROCORTISONETABLET;ORAL5MGNoNo
002HYDROCORTISONEHYDROCORTISONETABLET;ORAL10MGNoNo
003HYDROCORTISONEHYDROCORTISONETABLET;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040761-001HYDROCORTISONEHYDROCORTISONE5MGTABLET / ORAL2007-07-16
A040761-002HYDROCORTISONEHYDROCORTISONE10MGTABLET / ORAL2007-07-16
A040761-003HYDROCORTISONEHYDROCORTISONE20MGTABLET / ORAL2007-07-16

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-1684e616aacf4f…
2026-08-18 06:07:402026-07A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040761-002HYDROCORTISONE10MGTABLET / ORAL2007-07-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040761-003HYDROCORTISONE20MGTABLET / ORAL2007-07-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040761-001HYDROCORTISONE5MGTABLET / ORAL2007-07-16301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040761-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040761-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040761-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A040761-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040761-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040761-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040761-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040761-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040761-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040761-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040761-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040761-003AB1ea99ee380514…

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 1 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsName fallback
generic name: HYDROCORTISONE
Terramed Just Think Comfort Hydrocortisone 1% CreamHYDROCORTISONERida LLC0d2c0c2c-370f-4adb-b0ea-1e218c927f8b2026-09-01WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEAmerican Health Packaging506aab0d-9308-4d60-90b3-7d64952fff362026-08-31Warnings, Adverse reactionsName fallback
brand name: Hydrocortisone
generic name: HYDROCORTISONE
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinHYDROCORTISONEAmerisourceBergenc5c5b5ca-b4d4-4fa8-b647-b3ccb29664952026-08-30WarningsName fallback
generic name: HYDROCORTISONE
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEAmazon.com Services LLC5f87d7fb-f258-48b0-8b60-1055e22ebd712026-08-25WarningsName fallback
brand name: Hydrocortisone
generic name: HYDROCORTISONE
ANTI ITCHHYDROCORTISONEHyVee Inc1ab6bbb8-2b91-4c53-9168-b1e85ac296e92026-08-19WarningsName fallback
generic name: HYDROCORTISONE
hydrocortisone 1HYDROCORTISONEKroger Companyf05edff2-2dc5-427c-b52c-518e0aaef4e02026-08-19WarningsName fallback
generic name: HYDROCORTISONE
MedPrideHYDROCORTISONEShield Line LLC2f15d3b3-d1e6-4742-9eac-f956c0ffbba42026-08-18WarningsName fallback
generic name: HYDROCORTISONE
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsName fallback
brand name: Hydrocortisone
generic name: HYDROCORTISONE
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsName fallback
brand name: HYDROCORTISONE
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONESolco Healthcare LLC04f112e5-ec88-46c8-b675-8b4e38a86ab42026-08-11Warnings, Adverse reactionsName fallback
brand name: Hydrocortisone
generic name: HYDROCORTISONE
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsName fallback
generic name: HYDROCORTISONE
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsName fallback
generic name: HYDROCORTISONE
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack484fe5e4-a058-49c0-a382-c8fc3e20c3b22026-08-04WarningsName fallback
brand name: hydrocortisone
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEREMEDYREPACK INC.f0e66726-946b-4f63-b457-2851dc69e6b42026-08-03Adverse reactionsName fallback
brand name: Hydrocortisone
generic name: HYDROCORTISONE
Cortizone 10 Itch Relief Massaging RollerballHYDROCORTISONEChattem, Inc.1e27682c-f856-41f1-9935-37540960a4c72026-07-31WarningsName fallback
generic name: HYDROCORTISONE
hydrocortisoneHYDROCORTISONEEywa Pharma Incb3f06d10-2f01-428c-88a4-505c61c87ce82026-07-25Warnings, Adverse reactionsName fallback
brand name: hydrocortisone
generic name: HYDROCORTISONE
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsName fallback
generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-3899HydrocortisonehydrocortisonePar PharmaceuticalANDACurrent
0603-3900HydrocortisonehydrocortisonePar PharmaceuticalANDACurrent
0603-3901HydrocortisonehydrocortisonePar PharmaceuticalANDACurrent
43063-208HydrocortisonehydrocortisonePD-Rx Pharmaceuticals, InANDACurrent
68084-469HydrocortisonehydrocortisoneAmerican Health PackagingANDACurrent
68084-789HydrocortisonehydrocortisoneAmerican Health PackagingANDACurrent
68084-930HydrocortisonehydrocortisoneAmerican Health PackagingANDACurrent
68151-4021HydrocortisonehydrocortisoneCarilion Materials ManagementANDACurrent