Home NDC 59651-413 HYDROCORTISONE
Product NDC 59651-413
11-digit product format 596510413
Labeler code 59651
Product ID 59651-413_a5daf751-ebbc-4c2c-8169-2dfd9146a4b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCORTISONE
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA214649
Marketing category ANDA
Marketing start 2023-07-17
Substance HYDROCORTISONE
Active strength 5 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214649-001 HYDROCORTISONE HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 A214649-002 HYDROCORTISONE HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 A214649-003 HYDROCORTISONE HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2 · 69 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214649-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2023-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214649-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2023-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214649-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2023-07-17 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 69 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base HYDROCORTISONE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-413-50 HYDROCORTISONE 50 in 1 BOTTLE TABLET 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-413 HYDROCORTISONE TABLET [AUROBINDO PHARMA LIMITED] 3 Current NDC, 1 package rows 20240620_6d820911-f50e-46a4-8174-c4ee89f6792e.zip
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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-413-50 59651041350 50 TABLET in 1 BOTTLE (59651-413-50) 50 tablet 2023-07-17 No No Current