Home NDC 68791-104 PEDIAPRED
Product NDC 68791-104
11-digit product format 687910104
Labeler code 68791
Product ID 68791-104_5e5a5e2b-b12a-42d8-b375-11fbffb050b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisolone Sodium Phosphate
Dosage form SOLUTION
Route ORAL
Labeler Royal Pharmaceuticals
Application NDA019157
Marketing category NDA
Marketing start 2018-02-07
Marketing end 0000-00-00
Substance PREDNISOLONE SODIUM PHOSPHATE
Active strength 5 mg/5mL
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 68791-104 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68791-104 68791-104-04 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N019157-001 PEDIAPRED PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019157-001 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 · 42 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 2026-08-18 06:07:40 2026-07 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68791-104 PEDIAPRED (PREDNISOLONE SODIUM PHOSPHATE) SOLUTION [ROYAL PHARMACEUTICALS] 4 Legacy NDC 20240203_1b996564-a777-4d37-ae00-b6a5ffc5e596.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 · 2 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 68791-104-04 68791010404 120 mL in 1 BOTTLE (68791-104-04) 120 ml 2018-02-07 0000-00-00 No No Current