FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
63323-516
11-digit product format
633230516
Labeler code
63323
Product ID
63323-516_9320abbb-bfd8-4df2-9269-3a52736c190f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXAMETHASONE SODIUM PHOSPHATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA040572
Marketing category
ANDA
Marketing start
2005-04-05
Substance
DEXAMETHASONE SODIUM PHOSPHATE
Active strength
10 mg/mL
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
Dexamethasone Sodium Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE SODIUM PHOSPHATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAI9376Y64P
Rxcui309696, 1812079

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-516-01Dexamethasone Sodium Phosphate10 mL in 1 VIALINJECTION, SOLUTION1011
63323-516-10Dexamethasone Sodium Phosphate10 in 1 TRAYINJECTION, SOLUTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-516-01ML - Milliliter63323-5163730edd9-e959-4a29-8817-9a8f025b511a12024-11-05
63323-516-10ML - Milliliter63323-516d7f3c390-399d-47c9-94c4-a130752907ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-516DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]9Current NDC, Legacy NDC, 2 package rows20240725_cca2c160-9188-48e8-9505-49a52388dcb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812079dexAMETHasone sodium phosphate 10 MG in 1 ML InjectionPSNcca2c160-9188-48e8-9505-49a52388dcb711
309696dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNcca2c160-9188-48e8-9505-49a52388dcb711
18120791 ML dexamethasone phosphate 10 MG/ML InjectionSCDcca2c160-9188-48e8-9505-49a52388dcb711
309696dexamethasone phosphate 10 MG/ML Injectable SolutionSCDcca2c160-9188-48e8-9505-49a52388dcb711
1812079dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML InjectionSYcca2c160-9188-48e8-9505-49a52388dcb711
309696dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable SolutionSYcca2c160-9188-48e8-9505-49a52388dcb711
309696dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN946f3c1d-0362-d602-e053-2995a90a3d9a5
309696dexamethasone phosphate 10 MG/ML Injectable SolutionSCD946f3c1d-0362-d602-e053-2995a90a3d9a5
309696dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable SolutionSY946f3c1d-0362-d602-e053-2995a90a3d9a5
309696dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNa86f83b1-e32a-4ac5-ac14-6b2f683b7bf83
309696dexamethasone phosphate 10 MG/ML Injectable SolutionSCDa86f83b1-e32a-4ac5-ac14-6b2f683b7bf83
309696dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable SolutionSYa86f83b1-e32a-4ac5-ac14-6b2f683b7bf83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-516-016332305160110 mL in 1 VIAL10 mlHistorical
63323-516-106332305161010 VIAL in 1 TRAY (63323-516-10) / 10 mL in 1 VIAL (63323-516-01) 10 vial2005-04-050000-00-00NoNoCurrent