Home NDC 17856-0815 Prednisolone Sodium Phosphate
Product NDC 17856-0815
11-digit product format 178560815
Labeler code 17856
Product ID 17856-0815_5aae5bcf-6f28-c44b-e063-6394a90afd94
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisolone Sodium Phosphate
Dosage form SOLUTION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA203559
Marketing category ANDA
Marketing start 2023-10-09
Substance PREDNISOLONE SODIUM PHOSPHATE
Active strength 15 mg/5mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203559-001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 A203559-002 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 A203559-003 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 A203559-004 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA 2023-02-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 4 · 140 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 2026-10-15 13:18:30 2026-09 A203559-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203559-002 PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203559-003 PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203559-004 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203559-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203559-002 PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203559-003 PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203559-004 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203559-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203559-002 PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203559-003 PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203559-004 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203559-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203559-002 PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203559-003 PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203559-004 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203559-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203559-002 PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203559-003 PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203559-004 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203559-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203559-002 PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203559-003 PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203559-004 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203559-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203559-002 PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203559-003 PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203559-004 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203559-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203559-002 PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203559-003 PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203559-004 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203559-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203559-002 PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203559-003 PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203559-004 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203559-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203559-002 PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2016-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203559-003 PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203559-004 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA 2023-02-06 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 4 · 140 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Prednisolone Sodium Phosphate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISOLONE SODIUM PHOSPHATE 15 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 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 17856-0815-1 Prednisolone Sodium Phosphate 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 2 17856-0815-1 Prednisolone Sodium Phosphate 72 in 1 BOX, UNIT-DOSE SOLUTION 72 2 17856-0815-2 Prednisolone Sodium Phosphate 72 in 1 BOX, UNIT-DOSE SOLUTION 72 2 17856-0815-2 Prednisolone Sodium Phosphate 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 2 17856-0815-3 Prednisolone Sodium Phosphate 48 in 1 BOX, UNIT-DOSE SOLUTION 48 2 17856-0815-3 Prednisolone Sodium Phosphate 5 mL in 1 SYRINGE SOLUTION 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0815 PREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORP.] 2 Current NDC, 6 package rows 20250524_96de9cad-2fb7-4947-87ae-4db57563a83a.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 · 5 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 17856-0815-1 17856081501 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-1) / 5 mL in 1 CUP, UNIT-DOSE 2025-01-15 No No Current 17856-0815-2 17856081502 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-2) / 10 mL in 1 CUP, UNIT-DOSE 2025-01-15 No No Current 17856-0815-3 17856081503 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0815-3) / 5 mL in 1 SYRINGE 48 syringe 2025-01-15 No No Current 17856-0815-5 17856081505 45 SYRINGE in 1 BOX, UNIT-DOSE (17856-0815-5) / 5 mL in 1 SYRINGE 45 syringe 2026-09-04 No No Current