Home NDC 13925-166 Prednisolone Sodium Phosphate
Product NDC 13925-166
11-digit product format 139250166
Labeler code 13925
Product ID 13925-166_da94c24a-0943-4544-8286-467d7c073c34
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisolone Sodium Phosphate
Dosage form SOLUTION
Route ORAL
Labeler Seton Pharmaceuticals, LLC
Application NDA019157
Marketing category NDA
Marketing start 2013-10-18
Substance PREDNISOLONE SODIUM PHOSPHATE
Active strength 5 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 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 · 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 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Prednisolone Sodium Phosphate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISOLONE SODIUM PHOSPHATE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IV021NXA9J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312614 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13925-166-04 Prednisolone Sodium Phosphate 120 mL in 1 BOTTLE SOLUTION 120 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PREDNISOLONE SODIUM PHOSPHATE ACTIVE INGREDIENT IV021NXA9J PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] 3 PREDNISOLONE ACTIVE MOIETY 9PHQ9Y1OLM PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] 3 RASPBERRY INACTIVE INGREDIENT 4N14V5R27W PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] 3 SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE INACTIVE INGREDIENT 70WT22SF4B PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] 3 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] 3 WATER INACTIVE INGREDIENT 059QF0KO0R PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13925-166 PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] 7 Current NDC, Legacy NDC, 1 package rows 20240925_833ba492-8823-43b4-9a91-8b28d94a740b.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13925-166-04 13925016604 120 mL in 1 BOTTLE (13925-166-04) 120 ml 2013-10-18 0000-00-00 No No Current