Home NDC 0603-5336 Prednisone
Product NDC 0603-5336
11-digit product format 006035336
Labeler code 0603
Product ID 0603-5336_e6628b5c-a3e4-462b-a01a-695ed8d3ab64
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisone
Dosage form TABLET
Route ORAL
Labeler Endo USA, Inc.
Application ANDA040581
Marketing category ANDA
Marketing start 2004-12-21
Substance PREDNISONE
Active strength 2.5 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 A040581-001 PREDNISONE PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040581-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Prednisone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISONE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VB0R961HZT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 9 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198144 Internal RxNorm lookup 198145 Internal RxNorm lookup 198146 Internal RxNorm lookup 312615 Internal RxNorm lookup 312617 Internal RxNorm lookup 763179 Internal RxNorm lookup 763181 Internal RxNorm lookup 763183 Internal RxNorm lookup 763185 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2022-08-19 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 2022-08-19 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 2022-08-19 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 2022-07-29 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 2022-07-29 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 2022-07-29 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0603-5336-21 Prednisone 100 in 1 BOTTLE, PLASTIC TABLET 100 32
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0603-5336 PREDNISONE TABLET [ENDO USA, INC.] 32 Current NDC, Legacy NDC, 1 package rows 20240927_10fe5a3b-84dc-4600-87c2-b80c97ce18cf.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0603-5336-21 00603533621 100 TABLET in 1 BOTTLE, PLASTIC (0603-5336-21) 100 tablet 2004-12-21 0000-00-00 No No Current