FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
21695-847
11-digit product format
216950847
Labeler code
21695
Product ID
21695-847_a2c2385e-74a8-4a18-92ec-be8a1380e13a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexamethasone sodium phosphate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
ANDA088771
Marketing category
ANDA
Marketing start
1985-01-16
Marketing end
0000-00-00
Substance
DEXAMETHASONE SODIUM PHOSPHATE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-847-052019-09-24C16284748780-1934fe258-49a1-48b1-e053-8cdaa90a720aDexamethasone Sodium Phosphate Ophthalmic Solution, USP Equivalent to dexamethasone phosphate 0.1% STERILE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-847-05Dexamethasone Sodium Phosphate5 mL in 1 BOTTLE, PLASTICSOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-847-05ML - Milliliter21695-847ed2323f1-b242-49dc-a6ca-ea861546562c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dexamethasone sodium phosphateACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
dexamethasoneACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KDEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XDEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74DEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-847DEXAMETHASONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101220_a2c2385e-74a8-4a18-92ec-be8a1380e13a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226343dexAMETHasone sodium phosphate 0.1 % Ophthalmic SolutionPSNa2c2385e-74a8-4a18-92ec-be8a1380e13a1
226343dexamethasone phosphate 1 MG/ML Ophthalmic SolutionSCDa2c2385e-74a8-4a18-92ec-be8a1380e13a1
226343dexamethasone sodium phosphate 0.1 % Ophthalmic SolutionSYa2c2385e-74a8-4a18-92ec-be8a1380e13a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-847-05216950847055 mL in 1 BOTTLE, PLASTIC5 mlHistorical