Home NDC 68071-3958-9 PREDNISONE
Product NDC 68071-3958
Requested package NDC 68071-3958-9
11-digit product format 680713958
Labeler code 68071
Product ID 68071-3958_5b9c9d04-85e0-876e-e063-6294a90a57af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PREDNISONE
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA215671
Marketing category ANDA
Marketing start 2021-11-16
Substance PREDNISONE
Active strength 1 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 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 A215671-001 PREDNISONE PREDNISONE 1MG TABLET / ORAL AB 2021-11-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215671-001 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.
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 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215671-001 PREDNISONE 1MG TABLET / ORAL AB 2021-11-16 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PREDNISONE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISONE 1 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-3958-9 PREDNISONE 90 in 1 BOTTLE TABLET 90 1
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 · 2 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 68071-3958-9 68071395809 90 TABLET in 1 BOTTLE (68071-3958-9) 90 tablet 2026-01-26 No No Current