FDA.reportPublic FDA data

Prednisolone Sodium Phosphate

Product NDC
62135-330
11-digit product format
621350330
Labeler code
62135
Product ID
62135-330_4abaeb5a-975a-41b9-e063-6294a90ac367
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisolone sodium phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA075988
Marketing category
ANDA
Marketing start
2004-05-25
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
5 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

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 PHOSPHATE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIV021NXA9J
Rxcui312614

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product 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
62135-330-05Prednisolone Sodium Phosphate5 mL in 1 CUPSOLUTION511
62135-330-24Prednisolone Sodium Phosphate2 in 1 BOXSOLUTION211
62135-330-24Prednisolone Sodium Phosphate10 in 1 TRAYSOLUTION1011
62135-330-41Prednisolone Sodium Phosphate120 mL in 1 BOTTLESOLUTION12011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-330-05ML - Milliliter62135-330c0308c10-cb18-4822-a6ee-24e86535424912024-11-05
62135-330-24ML - Milliliter62135-3309b00c172-b187-4e6c-9594-94d6afa8696a12024-11-05
62135-330-41ML - Milliliter62135-33066095f46-fdf4-4607-babd-4c666d7e68c212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-330PREDNISOLONE SODIUM PHOSPHATE SOLUTION [CHARTWELL RX, LLC.]10Current NDC, Legacy NDC, 4 package rows20241018_2d8c861d-3756-4b75-aaa9-1b82cf11eb94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312614prednisoLONE sodium phosphate 5 MG in 5 mL Oral SolutionPSN2d8c861d-3756-4b75-aaa9-1b82cf11eb9411
312614prednisolone 1 MG/ML Oral SolutionSCD2d8c861d-3756-4b75-aaa9-1b82cf11eb9411
312614prednisolone 5 MG (as prednisolone sodium phosphate 6.7 MG) per 5 ML Oral SolutionSY2d8c861d-3756-4b75-aaa9-1b82cf11eb9411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-330-05621350330055 mL in 1 CUP5 mlHistorical
62135-330-24621350330242 TRAY in 1 BOX (62135-330-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-330-05) 2 tray2024-10-14NoNoCurrent
62135-330-4162135033041120 mL in 1 BOTTLE (62135-330-41) 120 ml2021-05-080000-00-00NoNoCurrent