Home NDC 71930-078 hydrocortisone
Product NDC 71930-078
11-digit product format 719300078
Labeler code 71930
Product ID 71930-078_2577dbe5-22bd-4da5-9ff8-b88c9dc1ec62
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocortisone
Dosage form TABLET
Route ORAL
Labeler Eywa Pharma Inc
Application ANDA217160
Marketing category ANDA
Marketing start 2022-10-07
Substance HYDROCORTISONE
Active strength 5 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A217160-001 HYDROCORTISONE HYDROCORTISONE 5MG TABLET / ORAL AB 2024-11-25 A217160-002 HYDROCORTISONE HYDROCORTISONE 10MG TABLET / ORAL AB 2024-11-25 A217160-003 HYDROCORTISONE HYDROCORTISONE 20MG TABLET / ORAL AB 2024-11-25
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.
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 2026-02-19 14:30 UTC 2026-02 A217160-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2024-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217160-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2024-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217160-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2024-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217160-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2024-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217160-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2024-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217160-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2024-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217160-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2024-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217160-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2024-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217160-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2024-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217160-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2024-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217160-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2024-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217160-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2024-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217160-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2024-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217160-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2024-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217160-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2024-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217160-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2024-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217160-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2024-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217160-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2024-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217160-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2024-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217160-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2024-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217160-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2024-11-25 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217160-001 HYDROCORTISONE 5MG TABLET / ORAL AB 2024-11-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217160-002 HYDROCORTISONE 10MG TABLET / ORAL AB 2024-11-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217160-003 HYDROCORTISONE 20MG TABLET / ORAL AB 2024-11-25 a50c72e98297…
Observed Orange Book normalized TE history# 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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197782 Internal RxNorm lookup 197783 Internal RxNorm lookup 197787 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71930-078-50 hydrocortisone 50 in 1 BOTTLE TABLET 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71930-078 HYDROCORTISONE TABLET [EYWA PHARMA INC] 2 Current NDC, 1 package rows 20250403_b3f06d10-2f01-428c-88a4-505c61c87ce8.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 71930-078-50 71930007850 50 TABLET in 1 BOTTLE (71930-078-50) 50 tablet 2022-10-07 No No Current