Home NDC 68999-250 Prednisolone
Product NDC 68999-250
11-digit product format 689990250
Labeler code 68999
Product ID 68999-250_43e3bba6-a836-f5e7-e063-6294a90a10e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisolone oral
Dosage form SOLUTION
Route ORAL
Labeler Chartwell Governmental & Specialty RX, LLC.
Application ANDA040323
Marketing category ANDA
Marketing start 2022-11-20
Substance PREDNISOLONE
Active strength 15 mg/5mL
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 1 .
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 A040323-001 PREDNISOLONE PREDNISOLONE 15MG/5ML SOLUTION / ORAL AA RS 1999-05-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040323-001 AA
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A040323-001 PREDNISOLONE 15MG/5ML SOLUTION / ORAL AA RS 1999-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040323-001 PREDNISOLONE 15MG/5ML SOLUTION / ORAL AA RS 1999-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040323-001 PREDNISOLONE 15MG/5ML SOLUTION / ORAL AA RS 1999-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL 1999-05-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA RS 1999-05-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040323-001 PREDNISOLONE 15MG/5ML SYRUP / ORAL AA 1999-05-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Prednisolone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISOLONE 15 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9PHQ9Y1OLM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283077 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 68999-250-24 Prednisolone 2 in 1 BOX SOLUTION 2 1 68999-250-24 Prednisolone 10 in 1 TRAY SOLUTION 10 1 68999-250-45 Prednisolone 5 mL in 1 CUP SOLUTION 5 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 · 3 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 68999-250-24 68999025024 2 TRAY in 1 BOX (68999-250-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-250-45) 2 tray 2025-11-14 No No Current 68999-250-45 68999025045 5 mL in 1 CUP 5 ml Historical