FDA.reportPublic FDA data

Prednisolone Sodium Phosphate

Product NDC
70166-549
11-digit product format
701660549
Labeler code
70166
Product ID
70166-549_95993186-3783-9ff6-e053-2a95a90adffb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Lohxa
Application
ANDA076913
Marketing category
ANDA
Marketing start
2005-04-25
Marketing end
0000-00-00
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
15 mg/5mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70166-549-052023-01-30C16284748780-1f386c649-d1bb-0266-e053-dadaa90a7c1aPREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (15 mg Prednisolone Base per 5 mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70166-549-05Prednisolone Sodium Phosphate5 mL in 1 CUP, UNIT-DOSESOLUTION51
70166-549-05Prednisolone Sodium Phosphate50 in 1 BOXSOLUTION501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70166-549-05ML - Milliliter70166-549b39e391d-5647-4760-b356-55b2406c15f412020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70166-549PREDNISOLONE SODIUM PHOSPHATE SOLUTION [LOHXA]1Legacy NDC, 2 package rows20191024_c266e029-808b-42dc-ae5b-e73e2c9d92d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70166-549-057016605490550 CUP, UNIT-DOSE in 1 BOX (70166-549-05) > 5 mL in 1 CUP, UNIT-DOSE2019-06-010000-00-00NoNoCurrent