Dexamethasone Sodium Phosphate

Product NDC
57319-065
11-digit product format
573190065
Labeler code
57319
Product ID
57319-065_580b36d2-1400-4096-aff1-cbc1f6d0ad4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Phoenix Pharmaceutical, Inc.
Application
ANDA040069
Marketing category
ANDA
Marketing start
1996-07-26
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
57319-065-012019-10-29C16284748780-1960f7f55-d853-8e05-e053-dbdaa90a074aDexamethasone Sodium Phosphate Ophthalmic Solution USP, 0.1% Dexamethasone Phosphate Equivalent (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57319-065-01Dexamethasone Sodium Phosphate1 in 1 CARTONSOLUTION/ DROPS11
57319-065-01Dexamethasone Sodium Phosphate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57319-065-01ML - Milliliter57319-065fb592ae9-698e-40a6-85ab-7a4a85d435d012022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1
CREATININEINACTIVE INGREDIENTAYI8EX34EUDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1
PHENETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468DEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1
SODIUM BISULFITEINACTIVE INGREDIENTTZX5469Z6IDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QODEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57319-065DEXAMETHASONE SODIUM PHOSPHATE SOLUTION/ DROPS [PHOENIX PHARMACEUTICAL, INC.]1Legacy NDC, 2 package rows20101213_580b36d2-1400-4096-aff1-cbc1f6d0ad4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226343dexAMETHasone sodium phosphate 0.1 % Ophthalmic SolutionPSN580b36d2-1400-4096-aff1-cbc1f6d0ad4c1
226343dexamethasone phosphate 1 MG/ML Ophthalmic SolutionSCD580b36d2-1400-4096-aff1-cbc1f6d0ad4c1
226343dexamethasone sodium phosphate 0.1 % Ophthalmic SolutionSY580b36d2-1400-4096-aff1-cbc1f6d0ad4c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
57319-065-01573190065011 in 1 CARTONHistorical