Prednisolone Sodium Phosphate

Product NDC
63187-215
11-digit product format
631870215
Labeler code
63187
Product ID
63187-215_10b381fc-624f-485b-a31f-15d46600232d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076913
Marketing category
ANDA
Marketing start
2005-04-25
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
2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076913-001PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076913-001AA

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-253f01610625f2…
2019-09-15 20:21 UTC2019-09A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076913-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076913-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076913-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076913-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076913-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076913-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076913-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076913-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076913-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076913-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076913-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076913-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076913-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076913-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076913-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076913-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076913-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076913-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076913-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076913-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076913-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076913-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A076913-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076913-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076913-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076913-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A076913-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076913-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076913-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076913-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076913-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076913-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076913-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076913-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076913-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076913-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076913-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076913-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076913-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076913-001AA1e64feba35796…

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 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
14b7f41b-4df1-42cb-bd1b-c74b28de2670Available 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
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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
63187-215-64Prednisolone Sodium Phosphate240 mL in 1 BOTTLESOLUTION2404

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Prednisolone Sodium PhosphateACTIVE INGREDIENTIV021NXA9JPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
PrednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
Corn SyrupINACTIVE INGREDIENT9G5L16BK6NPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
Hydroxyethyl Cellulose (140 MPA.S at 5%)INACTIVE INGREDIENT8136Y38GY5PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
Potassium Phosphate, DibasicINACTIVE INGREDIENTCI71S98N1ZPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
Potassium Phosphate, MonobasicINACTIVE INGREDIENT4J9FJ0HL51PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
WaterINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-215PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]4Current NDC, Legacy NDC, 1 package rows20210121_14b7f41b-4df1-42cb-bd1b-c74b28de2670.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPreferred Pharmaceuticals, Inc.93b372f7-b811-4c15-85c4-c6dbac342cb42026-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076913
application number: ANDA076913
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEREMEDYREPACK INC.f87ce1ba-335e-463d-87d5-9af0206f8f612026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076913
application number: ANDA076913
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharmaa0d74ae0-7b2d-4d36-9211-c76f5063b5a92025-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076913
application number: ANDA076913
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEA-S Medication Solutions4c507319-8add-4952-8bea-ff77ab17088f2025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076913
application number: ANDA076913
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEProficient Rx LP14b7f41b-4df1-42cb-bd1b-c74b28de26702021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076913
application number: ANDA076913
ndc (product): 63187-215

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN14b7f41b-4df1-42cb-bd1b-c74b28de26704
283077prednisolone 3 MG/ML Oral SolutionSCD14b7f41b-4df1-42cb-bd1b-c74b28de26704
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY14b7f41b-4df1-42cb-bd1b-c74b28de26704
283077prednisolone 15 MG per 5 ML Oral SolutionSY14b7f41b-4df1-42cb-bd1b-c74b28de26704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-215-6463187021564240 mL in 1 BOTTLE (63187-215-64) 240 ml2014-09-010000-00-00NoNoCurrent