Home NDC 72789-401 Prednisone
Product NDC 72789-401
11-digit product format 727890401
Labeler code 72789
Product ID 72789-401_57c3c7f3-6773-e42a-e063-6294a90a3263
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisone
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA211575
Marketing category ANDA
Marketing start 2019-11-15
Substance PREDNISONE
Active strength 10 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 · 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 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198145 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 72789-401-10 Prednisone 10 in 1 BOTTLE, PLASTIC TABLET 10 13 72789-401-12 Prednisone 12 in 1 BOTTLE, PLASTIC TABLET 12 13 72789-401-20 Prednisone 20 in 1 BOTTLE, PLASTIC TABLET 20 13 72789-401-21 Prednisone 21 in 1 BOTTLE, PLASTIC TABLET 21 13 72789-401-30 Prednisone 30 in 1 BOTTLE, PLASTIC TABLET 30 13 72789-401-40 Prednisone 40 in 1 BOTTLE, PLASTIC TABLET 40 13 72789-401-42 Prednisone 42 in 1 BOTTLE, PLASTIC TABLET 42 13 72789-401-50 Prednisone 50 in 1 BOTTLE, PLASTIC TABLET 50 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-401 PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.] 13 Current NDC, 8 package rows 20250221_19fdbf9f-3a64-b9fa-e063-6394a90af086.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 72789-401-10 72789040110 10 TABLET in 1 BOTTLE, PLASTIC (72789-401-10) 10 tablet 2024-06-04 No No Current 72789-401-12 72789040112 12 TABLET in 1 BOTTLE, PLASTIC (72789-401-12) 12 tablet 2024-07-10 No No Current 72789-401-20 72789040120 20 TABLET in 1 BOTTLE, PLASTIC (72789-401-20) 20 tablet 2024-06-20 No No Current 72789-401-21 72789040121 21 TABLET in 1 BOTTLE, PLASTIC (72789-401-21) 21 tablet 2024-06-25 No No Current 72789-401-30 72789040130 30 TABLET in 1 BOTTLE, PLASTIC (72789-401-30) 30 tablet 2024-06-03 No No Current 72789-401-40 72789040140 40 TABLET in 1 BOTTLE, PLASTIC (72789-401-40) 40 tablet 2024-06-03 No No Current 72789-401-42 72789040142 42 TABLET in 1 BOTTLE, PLASTIC (72789-401-42) 42 tablet 2025-01-10 No No Current 72789-401-50 72789040150 50 TABLET in 1 BOTTLE, PLASTIC (72789-401-50) 50 tablet 2024-06-03 No No Current