Home NDC 61919-365 PREDNISONE
Product NDC 61919-365
11-digit product format 619190365
Labeler code 61919
Product ID 61919-365_4d3fa8d2-31a1-759a-e063-6294a90a0267
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PREDNISONE
Dosage form TABLET
Route ORAL
Labeler DIRECT RX
Application ANDA040584
Marketing category ANDA
Marketing start 2014-01-01
Substance PREDNISONE
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-365-21 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-365-21 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-365-21 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-365-21 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-365-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-365-21 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-365-21 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-365-21 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-365-21 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 61919-365-21 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A040584-001 PREDNISONE PREDNISONE 1MG 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 A040584-001 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 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040584-001 PREDNISONE 1MG TABLET / ORAL AB 2004-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040584-001 PREDNISONE 1MG 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312617 Internal RxNorm lookup 763181 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-365-21 PREDNISONE 21 in 1 DOSE PACK TABLET 21 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-365 PREDNISONE TABLET [DIRECT RX] 4 Current NDC, Legacy NDC, 1 package rows 20230113_2a053775-6f6a-455e-b9a8-8b60e6062db3.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 · 5 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 61919-365-21 61919036521 21 TABLET in 1 DOSE PACK (61919-365-21) 21 tablet 2014-01-01 0000-00-00 No No Current