Home NDC 0378-0641 Prednisone
Product NDC 0378-0641
11-digit product format 003780641
Labeler code 0378
Product ID 0378-0641_f7cba7fb-7b9f-4464-a702-5c4f818aeb5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisone
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA088832
Marketing category ANDA
Marketing start 2019-04-03
Substance PREDNISONE
Active strength 10 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 .
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 2025-08-23 18:47 UTC 2025-08 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088832-001 PREDNISONE 10MG TABLET / ORAL AB 1985-12-04 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Prednisone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISONE 10 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198145 Internal RxNorm lookup 312615 Internal RxNorm lookup 312617 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 0378-0641-01 Prednisone 100 in 1 BOTTLE, PLASTIC TABLET 100 9 0378-0641-10 Prednisone 1000 in 1 BOTTLE, PLASTIC TABLET 1000 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-0641 PREDNISONE TABLET [MYLAN PHARMACEUTICALS INC.] 9 Current NDC, Legacy NDC, 2 package rows 20250221_fec09050-5ac2-451b-a2b9-5a21b2def212.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 · 3 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 0378-0641-01 00378064101 100 TABLET in 1 BOTTLE, PLASTIC (0378-0641-01) 100 tablet 2019-04-03 0000-00-00 No No Current 0378-0641-10 00378064110 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0641-10) 1000 tablet 2019-04-03 0000-00-00 No No Current