Home NDC 0121-0773 Prednisolone Sodium Phosphate
Product NDC 0121-0773
11-digit product format 001210773
Labeler code 0121
Product ID 0121-0773_cdc1335b-41fb-4df2-b201-69150adbb03d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisolone Sodium Phosphate
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA078465
Marketing category ANDA
Marketing start 2017-01-31
Substance PREDNISOLONE SODIUM PHOSPHATE
Active strength 10 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 A078465-001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078465-001 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 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 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 10 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 794979 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 0121-0773-08 Prednisolone Sodium Phosphate 237 mL in 1 BOTTLE SOLUTION 237 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0773 PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 7 Current NDC, Legacy NDC, 1 package rows 20250425_93cd0ddd-1cf5-4064-9a4c-015819c0065a.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 0121-0773-08 00121077308 237 mL in 1 BOTTLE (0121-0773-08) 237 ml 2017-01-31 0000-00-00 No No Current