FDA.reportPublic FDA data

Prednisolone Sodium Phosphate

Product NDC
42799-812
Requested package NDC
42799-812-01
11-digit product format
427990812
Labeler code
42799
Product ID
42799-812_462f70d9-438c-e6b2-e063-6394a90a1bbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA203559
Marketing category
ANDA
Marketing start
2011-11-11
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203559-001PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAA2016-12-20
A203559-002PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATEEQ 20MG BASE/5MLSOLUTION / ORALAA2016-12-20
A203559-003PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2023-02-06
A203559-004PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATEEQ 25MG BASE/5MLSOLUTION / ORALAA2023-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A203559-001AA
A203559-002AA
A203559-003AA
A203559-004AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A203559-001PREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAA2016-12-20a50c72e98297…
2026-08-01 22:54:322026-06A203559-002PREDNISOLONE SODIUM PHOSPHATEEQ 20MG BASE/5MLSOLUTION / ORALAA2016-12-20a50c72e98297…
2026-08-01 22:54:322026-06A203559-003PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2023-02-06a50c72e98297…
2026-08-01 22:54:322026-06A203559-004PREDNISOLONE SODIUM PHOSPHATEEQ 25MG BASE/5MLSOLUTION / ORALAA2023-02-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203559-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A203559-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A203559-003AA1a50c72e98297…
2026-08-01 22:54:322026-06A203559-004AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEATLANTIC BIOLOGICALS CORP.96de9cad-2fb7-4947-87ae-4db57563a83a2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203559
application number: ANDA203559
prednisoLONE sodium phosphatePREDNISOLONE SODIUM PHOSPHATEKesin Pharma4c0dcbfd-2848-9bd0-e063-6394a90af5a72026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203559
application number: ANDA203559
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATERedpharm Drug3253b63b-0533-6cdc-e063-6294a90aa3112025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203559
application number: ANDA203559
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEEdenbridge Pharmaceuticals LLC.1793e218-7b49-497d-879f-1020de6e6d682025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203559
application number: ANDA203559
ndc (package): 42799-812-01
ndc (product): 42799-812
ndc11 (package): 42799081201
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPreferred Pharmaceuticals Inc.7262fc84-3db2-4475-8ae4-6bec4477cb812025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203559
application number: ANDA203559
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEAtlantic Biologicals Corp401f7ba6-a4a2-9ae6-e063-6394a90a42102025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203559
application number: ANDA203559

Additional Listing Data#

Finished product
Yes
Brand name base
Prednisolone Sodium Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISOLONE SODIUM PHOSPHATE10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IV021NXA9JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
249066Internal RxNorm lookup
283077Internal RxNorm lookup
702306Internal RxNorm lookup
794979Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1793e218-7b49-497d-879f-1020de6e6d68Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
9f10552a-9a7b-8e6c-3223-dc44310af6cfProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42799-812-01Prednisolone Sodium Phosphate237 mL in 1 BOTTLE, PLASTICSOLUTION23714

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-812-01ML - Milliliter42799-81226952007-517f-4f85-aab7-1ccb7e8c4e6b12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-812PREDNISOLONE SODIUM PHOSPHATE SOLUTION [EDENBRIDGE PHARMACEUTICALS LLC.]12Current NDC, Legacy NDC, 1 package rows20250129_1793e218-7b49-497d-879f-1020de6e6d68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
794979prednisoLONE sodium phosphate 10 MG in 5 mL Oral SolutionPSN1793e218-7b49-497d-879f-1020de6e6d6814
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN1793e218-7b49-497d-879f-1020de6e6d6814
702306prednisoLONE sodium phosphate 20 MG in 5 mL Oral SolutionPSN1793e218-7b49-497d-879f-1020de6e6d6814
249066prednisoLONE sodium phosphate 25 MG in 5 mL Oral SolutionPSN1793e218-7b49-497d-879f-1020de6e6d6814
794979prednisolone 2 MG/ML Oral SolutionSCD1793e218-7b49-497d-879f-1020de6e6d6814
283077prednisolone 3 MG/ML Oral SolutionSCD1793e218-7b49-497d-879f-1020de6e6d6814
702306prednisolone 4 MG/ML Oral SolutionSCD1793e218-7b49-497d-879f-1020de6e6d6814
249066prednisolone 5 MG/ML Oral SolutionSCD1793e218-7b49-497d-879f-1020de6e6d6814
794979prednisolone 10 MG per 5 ML Oral SolutionSY1793e218-7b49-497d-879f-1020de6e6d6814
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY1793e218-7b49-497d-879f-1020de6e6d6814
283077prednisolone 15 MG per 5 ML Oral SolutionSY1793e218-7b49-497d-879f-1020de6e6d6814
702306prednisolone 20 MG (as prednisolone sodium phosphate 26.9 MG) per 5 ML Oral SolutionSY1793e218-7b49-497d-879f-1020de6e6d6814
249066prednisolone 25 MG (prednisolone sodium phosphate 33.6 MG) per 5 ML Oral SolutionSY1793e218-7b49-497d-879f-1020de6e6d6814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-812-0142799081201237 mL in 1 BOTTLE, PLASTIC (42799-812-01) 237 ml2011-11-110000-00-00NoNoCurrent