Home NDC 67046-1448 Prednisone
Product NDC 67046-1448
11-digit product format 670461448
Labeler code 67046
Product ID 67046-1448_2d99223a-8501-7640-e063-6394a90a260a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisone
Dosage form TABLET
Route ORAL
Labeler Coupler LLC
Application ANDA040581
Marketing category ANDA
Marketing start 2025-02-07
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 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 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 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040581-001 PREDNISONE 2.5MG TABLET / ORAL AB 2004-12-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Prednisone
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198146 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 67046-1448-3 Prednisone 30 in 1 BLISTER PACK TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67046-1448 PREDNISONE TABLET [COUPLER LLC] 1 Current NDC, 1 package rows 20250212_2d99223a-853a-7640-e063-6394a90a260a.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 Sample Exclude flag Status 67046-1448-3 67046144803 30 TABLET in 1 BLISTER PACK (67046-1448-3) 30 tablet 2025-02-07 No No Current