Prednisolone Sodium Phosphate

Product NDC
66993-845
11-digit product format
669930845
Labeler code
66993
Product ID
66993-845_4995189d-7448-4175-b720-8f1b7c1ff39e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisolone sodium phosphate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA021959
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-10-21
Marketing end
0000-00-00
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
15 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-845-35EA - Each66993-845339f447d-6d95-4392-8830-700122f71be112021-01-08
66993-845-51EA - Each66993-84505c62fc2-68e3-45f0-891a-f91d686c7e4a12020-04-20
66993-845-62EA - Each66993-845bb9dfe08-434d-43bb-925d-b9ac5a22c61912015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISOLONE SODIUM PHOSPHATEACTIVE INGREDIENTIV021NXA9JPREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13PREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOPREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4PREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1
SUCROSEINACTIVE INGREDIENTC151H8M554PREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-845PREDNISOLONE SODIUM PHOSPHATE ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING [PRASCO LABORATORIES]8Legacy NDC20240718_c1853cf5-1f60-4e5b-aeef-9bc907ea8b5f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-845-35669930845352 BLISTER PACK in 1 CARTON (66993-845-35) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (66993-845-51) 2 blister pack2020-10-010000-00-00NoNoCurrent
66993-845-62669930845628 BLISTER PACK in 1 CARTON (66993-845-62) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (66993-845-51) 8 blister pack2015-10-210000-00-00NoNoCurrent