Home NDC 42658-160 PREDNISOLONE
Product NDC 42658-160
11-digit product format 426580160
Labeler code 42658
Product ID 42658-160_9f93400d-a8c0-435a-ad65-48717cc455cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PREDNISOLONE
Dosage form TABLET
Route ORAL
Labeler Hisun Pharmaceuticals USA, Inc.
Application ANDA218083
Marketing category ANDA
Marketing start 2024-09-01
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 42 .
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 A218083-001 PREDNISOLONE PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218083-001 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 2026-08-18 06:07:40 2026-07 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218083-001 PREDNISOLONE 5MG TABLET / ORAL AB 2024-05-02 a50c72e98297…
Observed Orange Book normalized TE history# 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 42658-160-05 PREDNISOLONE 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42658-160 PREDNISOLONE TABLET [HISUN PHARMACEUTICALS USA, INC.] 1 Current NDC, 1 package rows 20240901_16d4e064-66d3-4497-8c7d-3aa355f91e1d.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 · 2 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 42658-160-05 42658016005 100 TABLET in 1 BOTTLE (42658-160-05) 100 tablet 2024-09-01 No No Current