Prednisolone Sodium Phosphate

Product NDC
0121-0759
11-digit product format
001210759
Labeler code
0121
Product ID
0121-0759_07592713-8b0b-47aa-8a7f-848823ff221c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
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
a0d74ae0-7b2d-4d36-9211-c76f5063b5a9Available 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0121-0759-08Prednisolone Sodium Phosphate237 mL in 1 BOTTLESOLUTION23716

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0759-08ML - Milliliter0121-0759739bcb40-cf85-4a4b-a196-2cf1ed5b33af12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISOLONE SODIUM PHOSPHATEACTIVE INGREDIENTIV021NXA9JPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
PrednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
corn syrupINACTIVE INGREDIENT9G5L16BK6NPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
glycerinINACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
potassium phosphate, dibasicINACTIVE INGREDIENTCI71S98N1ZPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
potassium phosphate, monobasicINACTIVE INGREDIENT4J9FJ0HL51PREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
waterINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
PREDNISOLONE SODIUM PHOSPHATEACTIVE INGREDIENTIV021NXA9JPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
POTASSIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTCI71S98N1ZPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
Prednisolone Sodium PhosphateACTIVE INGREDIENTIV021NXA9JPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
PrednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Corn SyrupINACTIVE INGREDIENT9G5L16BK6NPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Hydroxyethyl Cellulose (140 MPA.S at 5%)INACTIVE INGREDIENT8136Y38GY5PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Potassium Phosphate, DibasicINACTIVE INGREDIENTCI71S98N1ZPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Potassium Phosphate, MonobasicINACTIVE INGREDIENT4J9FJ0HL51PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Saccharin Sodium DihydrateINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Prednisolone Sodium PhosphateACTIVE INGREDIENTIV021NXA9JPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
PrednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5PREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
POTASSIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTCI71S98N1ZPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51PREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
WATERINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
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
0121-0759PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]14Current NDC, Legacy NDC, 1 package rows20240820_a0d74ae0-7b2d-4d36-9211-c76f5063b5a9.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
ndc (product): 0121-0759
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN6420303a-f493-45f6-b99c-1f3638894a5926
283077prednisolone 3 MG/ML Oral SolutionSCD6420303a-f493-45f6-b99c-1f3638894a5926
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY6420303a-f493-45f6-b99c-1f3638894a5926
283077prednisolone 15 MG per 5 ML Oral SolutionSY6420303a-f493-45f6-b99c-1f3638894a5926
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN4c507319-8add-4952-8bea-ff77ab17088f18
283077prednisolone 3 MG/ML Oral SolutionSCD4c507319-8add-4952-8bea-ff77ab17088f18
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY4c507319-8add-4952-8bea-ff77ab17088f18
283077prednisolone 15 MG per 5 ML Oral SolutionSY4c507319-8add-4952-8bea-ff77ab17088f18
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNa0d74ae0-7b2d-4d36-9211-c76f5063b5a916
283077prednisolone 3 MG/ML Oral SolutionSCDa0d74ae0-7b2d-4d36-9211-c76f5063b5a916
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYa0d74ae0-7b2d-4d36-9211-c76f5063b5a916
283077prednisolone 15 MG per 5 ML Oral SolutionSYa0d74ae0-7b2d-4d36-9211-c76f5063b5a916
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN50d651cc-e417-3b40-e054-00144ff8d46c7
283077prednisolone 3 MG/ML Oral SolutionSCD50d651cc-e417-3b40-e054-00144ff8d46c7
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY50d651cc-e417-3b40-e054-00144ff8d46c7
283077prednisolone 15 MG per 5 ML Oral SolutionSY50d651cc-e417-3b40-e054-00144ff8d46c7
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN93b372f7-b811-4c15-85c4-c6dbac342cb46
283077prednisolone 3 MG/ML Oral SolutionSCD93b372f7-b811-4c15-85c4-c6dbac342cb46
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY93b372f7-b811-4c15-85c4-c6dbac342cb46
283077prednisolone 15 MG per 5 ML Oral SolutionSY93b372f7-b811-4c15-85c4-c6dbac342cb46
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN5b3201f8-fa99-41bf-84c1-4e9355a58ce64
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN14b7f41b-4df1-42cb-bd1b-c74b28de26704
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN06caccd6-07df-4ca5-a5ca-3564bde3192a4
283077prednisolone 3 MG/ML Oral SolutionSCD5b3201f8-fa99-41bf-84c1-4e9355a58ce64
283077prednisolone 3 MG/ML Oral SolutionSCD14b7f41b-4df1-42cb-bd1b-c74b28de26704
283077prednisolone 3 MG/ML Oral SolutionSCD06caccd6-07df-4ca5-a5ca-3564bde3192a4
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY5b3201f8-fa99-41bf-84c1-4e9355a58ce64
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY14b7f41b-4df1-42cb-bd1b-c74b28de26704
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY06caccd6-07df-4ca5-a5ca-3564bde3192a4
283077prednisolone 15 MG per 5 ML Oral SolutionSY06caccd6-07df-4ca5-a5ca-3564bde3192a4
283077prednisolone 15 MG per 5 ML Oral SolutionSY5b3201f8-fa99-41bf-84c1-4e9355a58ce64
283077prednisolone 15 MG per 5 ML Oral SolutionSY14b7f41b-4df1-42cb-bd1b-c74b28de26704
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNf87ce1ba-335e-463d-87d5-9af0206f8f613
283077prednisolone 3 MG/ML Oral SolutionSCDf87ce1ba-335e-463d-87d5-9af0206f8f613
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYf87ce1ba-335e-463d-87d5-9af0206f8f613
283077prednisolone 15 MG per 5 ML Oral SolutionSYf87ce1ba-335e-463d-87d5-9af0206f8f613
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNc85891e4-4eb6-4546-9b68-61d560cbedba2
283077prednisolone 3 MG/ML Oral SolutionSCDc85891e4-4eb6-4546-9b68-61d560cbedba2
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYc85891e4-4eb6-4546-9b68-61d560cbedba2
283077prednisolone 15 MG per 5 ML Oral SolutionSYc85891e4-4eb6-4546-9b68-61d560cbedba2
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNc266e029-808b-42dc-ae5b-e73e2c9d92d81
283077prednisolone 3 MG/ML Oral SolutionSCDc266e029-808b-42dc-ae5b-e73e2c9d92d81
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYc266e029-808b-42dc-ae5b-e73e2c9d92d81
283077prednisolone 15 MG per 5 ML Oral SolutionSYc266e029-808b-42dc-ae5b-e73e2c9d92d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0759-0800121075908237 mL in 1 BOTTLE (0121-0759-08) 237 ml2005-04-250000-00-00NoNoCurrent