Home NDC 71335-2153-1 Prednisone
Product NDC 71335-2153
Requested package NDC 71335-2153-1
11-digit product format 713352153
Labeler code 71335
Product ID 71335-2153_0fc6e657-8df4-4a3e-808f-abbf2fcce124
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisone
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA040611
Marketing category ANDA
Marketing start 2005-06-06
Marketing end 0000-00-00
Substance PREDNISONE
Active strength 1 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A040611-001 PREDNISONE PREDNISONE 1MG TABLET / ORAL AB 2005-06-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040611-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-2153 PREDNISONE TABLET [BRYANT RANCH PREPACK] 101 Legacy NDC 20230608_e1f0600b-8e6c-4fe1-b687-0a34e6b9cab2.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-2153-1 71335215301 100 TABLET in 1 BOTTLE (71335-2153-1) 100 tablet 2022-08-22 0000-00-00 No No Current