prednisoLONE sodium phosphate

Product NDC
81033-021
11-digit product format
810330021
Labeler code
81033
Product ID
81033-021_4c0dce2f-a772-65cb-e063-6294a90a158e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisoLONE sodium phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Kesin Pharma
Application
ANDA203559
Marketing category
ANDA
Marketing start
2023-10-27
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 42.

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.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203559-001PREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAA2016-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A203559-002PREDNISOLONE SODIUM PHOSPHATEEQ 20MG BASE/5MLSOLUTION / ORALAA2016-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A203559-003PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2023-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A203559-004PREDNISOLONE SODIUM PHOSPHATEEQ 25MG BASE/5MLSOLUTION / ORALAA2023-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203559-001PREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAA2016-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203559-002PREDNISOLONE SODIUM PHOSPHATEEQ 20MG BASE/5MLSOLUTION / ORALAA2016-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203559-003PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2023-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203559-004PREDNISOLONE SODIUM PHOSPHATEEQ 25MG BASE/5MLSOLUTION / ORALAA2023-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203559-001PREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAA2016-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203559-002PREDNISOLONE SODIUM PHOSPHATEEQ 20MG BASE/5MLSOLUTION / ORALAA2016-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203559-003PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2023-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203559-004PREDNISOLONE SODIUM PHOSPHATEEQ 25MG BASE/5MLSOLUTION / ORALAA2023-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203559-001PREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAA2016-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203559-002PREDNISOLONE SODIUM PHOSPHATEEQ 20MG BASE/5MLSOLUTION / ORALAA2016-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203559-003PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2023-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203559-004PREDNISOLONE SODIUM PHOSPHATEEQ 25MG BASE/5MLSOLUTION / ORALAA2023-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203559-001PREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAA2016-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203559-002PREDNISOLONE SODIUM PHOSPHATEEQ 20MG BASE/5MLSOLUTION / ORALAA2016-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203559-003PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2023-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203559-004PREDNISOLONE SODIUM PHOSPHATEEQ 25MG BASE/5MLSOLUTION / ORALAA2023-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203559-001PREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAA2016-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203559-002PREDNISOLONE SODIUM PHOSPHATEEQ 20MG BASE/5MLSOLUTION / ORALAA2016-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203559-003PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2023-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203559-004PREDNISOLONE SODIUM PHOSPHATEEQ 25MG BASE/5MLSOLUTION / ORALAA2023-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203559-001PREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAA2016-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203559-002PREDNISOLONE SODIUM PHOSPHATEEQ 20MG BASE/5MLSOLUTION / ORALAA2016-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203559-003PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2023-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203559-004PREDNISOLONE SODIUM PHOSPHATEEQ 25MG BASE/5MLSOLUTION / ORALAA2023-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203559-001PREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAA2016-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203559-002PREDNISOLONE SODIUM PHOSPHATEEQ 20MG BASE/5MLSOLUTION / ORALAA2016-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203559-003PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2023-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203559-004PREDNISOLONE SODIUM PHOSPHATEEQ 25MG BASE/5MLSOLUTION / ORALAA2023-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203559-001PREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAA2016-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203559-002PREDNISOLONE SODIUM PHOSPHATEEQ 20MG BASE/5MLSOLUTION / ORALAA2016-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203559-003PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2023-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203559-004PREDNISOLONE SODIUM PHOSPHATEEQ 25MG BASE/5MLSOLUTION / ORALAA2023-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203559-001PREDNISOLONE SODIUM PHOSPHATEEQ 10MG BASE/5MLSOLUTION / ORALAA2016-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203559-002PREDNISOLONE SODIUM PHOSPHATEEQ 20MG BASE/5MLSOLUTION / ORALAA2016-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203559-003PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2023-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203559-004PREDNISOLONE SODIUM PHOSPHATEEQ 25MG BASE/5MLSOLUTION / ORALAA2023-02-06d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203559-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A203559-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A203559-003AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A203559-004AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203559-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203559-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203559-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203559-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203559-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203559-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203559-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203559-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203559-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203559-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203559-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203559-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203559-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203559-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203559-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203559-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203559-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203559-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203559-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203559-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203559-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203559-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203559-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203559-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203559-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203559-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203559-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203559-004AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203559-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203559-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203559-003AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203559-004AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203559-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203559-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203559-003AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203559-004AA1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
prednisoLONE sodium phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISOLONE SODIUM PHOSPHATE15 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c0dcbfd-2848-9bd0-e063-6394a90af5a7Available 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
81033-021-05prednisoLONE sodium phosphate5 mL in 1 CUP, UNIT-DOSESOLUTION51
81033-021-54prednisoLONE sodium phosphate50 in 1 CARTONSOLUTION501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-021-05ML - Milliliter81033-0217dd889e7-cca9-4036-9034-7aa49a2f91c012026-04-20
81033-021-54ML - Milliliter81033-021e0414667-e663-4472-90cf-995197a9772212026-04-20

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 · 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
ndc (product): 81033-021
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN4c0dcbfd-2848-9bd0-e063-6394a90af5a71
283077prednisolone 3 MG/ML Oral SolutionSCD4c0dcbfd-2848-9bd0-e063-6394a90af5a71
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY4c0dcbfd-2848-9bd0-e063-6394a90af5a71
283077prednisolone 15 MG per 5 ML Oral SolutionSY4c0dcbfd-2848-9bd0-e063-6394a90af5a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-021-05810330021055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-021-548103300215450 CUP, UNIT-DOSE in 1 CARTON (81033-021-54) / 5 mL in 1 CUP, UNIT-DOSE (81033-021-05) 2026-03-27NoNoCurrent