Home NDC 59651-491 PREDNISOLONE
Product NDC 59651-491
11-digit product format 596510491
Labeler code 59651
Product ID 59651-491_c535b93f-b31f-411f-848c-b5e6782f321f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PREDNISOLONE
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA215673
Marketing category ANDA
Marketing start 2023-03-17
Substance PREDNISOLONE
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215673-001 PREDNISOLONE PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215673-001 AB
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 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215673-001 PREDNISOLONE 5MG TABLET / ORAL AB 2023-03-17 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A215673-001 CGT 2023-11-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215673-001 CGT 2023-11-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215673-001 CGT 2023-11-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215673-001 CGT 2023-11-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215673-001 CGT 2023-11-18 3f0d92c62455…
Additional Listing Data#
Finished product Yes
Brand name base PREDNISOLONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISOLONE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9PHQ9Y1OLM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198142 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 59651-491-01 PREDNISOLONE 100 in 1 BOTTLE TABLET 100 2 59651-491-50 PREDNISOLONE 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 59651-491 PREDNISOLONE TABLET [AUROBINDO PHARMA LIMITED] 2 Current NDC, 2 package rows 20240301_070f1937-50a5-457f-bef5-4e597014e26d.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 59651-491-01 59651049101 100 TABLET in 1 BOTTLE (59651-491-01) 100 tablet 2023-03-17 No No Current 59651-491-50 59651049150 50 TABLET in 1 BOTTLE (59651-491-50) 50 tablet 2023-03-17 No No Current