Home NDC 68071-3637 Prednisone
Product NDC 68071-3637
11-digit product format 680713637
Labeler code 68071
Product ID 68071-3637_1c337a9d-7ee0-d3da-e063-6294a90af0b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisone
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA211575
Marketing category ANDA
Marketing start 2019-11-15
Substance PREDNISONE
Active strength 20 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 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211575-001 PREDNISONE PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 A211575-002 PREDNISONE PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 A211575-003 PREDNISONE PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 A211575-004 PREDNISONE PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 A211575-005 PREDNISONE PREDNISONE 50MG TABLET / ORAL AB 2019-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 5 · 200 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 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211575-001 PREDNISONE 2.5MG TABLET / ORAL AB 2019-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211575-002 PREDNISONE 5MG TABLET / ORAL AB 2019-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211575-003 PREDNISONE 10MG TABLET / ORAL AB 2019-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211575-004 PREDNISONE 20MG TABLET / ORAL AB 2019-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211575-005 PREDNISONE 50MG TABLET / ORAL AB 2019-11-15 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 200 observed states.
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISONE 20 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 312615 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 68071-3637-1 Prednisone 10 in 1 BOTTLE TABLET 10 1 68071-3637-3 Prednisone 3 in 1 BOTTLE TABLET 3 1 68071-3637-4 Prednisone 4 in 1 BOTTLE TABLET 4 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3637 PREDNISONE TABLET [NUCARE PHARMACEUTICALS,INC.] 1 Current NDC, 3 package rows 20240727_1c33879e-8b2b-5843-e063-6294a90adea4.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 2 of 2 · 21 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 68071-3637-1 68071363701 10 TABLET in 1 BOTTLE (68071-3637-1) 10 tablet 2024-07-01 No No Current 68071-3637-3 68071363703 3 TABLET in 1 BOTTLE (68071-3637-3) 3 tablet 2024-07-01 No No Current 68071-3637-4 68071363704 4 TABLET in 1 BOTTLE (68071-3637-4) 4 tablet 2024-07-01 No No Current