Home NDC 44523-182 Prednisolone Sodium Phosphate Oral Solution
Product NDC 44523-182
11-digit product format 445230182
Labeler code 44523
Product ID 44523-182_450e8d3f-b6f6-5251-e063-6394a90aa439
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisolone Sodium Phosphate
Dosage form SOLUTION
Route ORAL
Labeler BioComp Pharma, Inc.
Application ANDA091396
Marketing category ANDA
Marketing start 2019-10-28
Substance PREDNISOLONE SODIUM PHOSPHATE
Active strength 25 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 A091396-001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091396-001 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 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Prednisolone Sodium Phosphate Oral Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISOLONE SODIUM PHOSPHATE 25 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 249066 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 44523-182-08 Prednisolone Sodium Phosphate Oral Solution 237 mL in 1 BOTTLE SOLUTION 237 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44523-182 PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (PREDNISOLONE SODIUM PHOSPHATE) SOLUTION [BIOCOMP PHARMA, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20240607_95208441-1700-5d3f-e053-2a95a90a7da2.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 · 1 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 44523-182-08 44523018208 237 mL in 1 BOTTLE (44523-182-08) 237 ml 2019-10-28 0000-00-00 No No Current