FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
67457-422
11-digit product format
674570422
Labeler code
67457
Product ID
67457-422_dd5c82b6-a194-462c-9626-34a9b410cfea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler
Mylan Institutional LLC
Application
ANDA040803
Marketing category
ANDA
Marketing start
2011-05-11
Substance
DEXAMETHASONE SODIUM PHOSPHATE
Active strength
4 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexamethasone Sodium Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE SODIUM PHOSPHATE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAI9376Y64P
Rxcui309696, 1116927, 1812194

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-422-00Dexamethasone Sodium Phosphate5 mL in 1 VIALINJECTION, SOLUTION58
67457-422-54Dexamethasone Sodium Phosphate25 in 1 CARTONINJECTION, SOLUTION258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-422-54ML - Milliliter67457-422fc365144-cc0b-4630-98e0-017d9cf34ef712014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]5
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]5
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGADEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-422DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]8Current NDC, Legacy NDC, 2 package rows20240321_dff598e8-e662-411f-978d-4ba3fb8ef7db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSNd21f3055-8a8a-4797-93e2-c8f582cbdae124
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNd21f3055-8a8a-4797-93e2-c8f582cbdae124
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCDd21f3055-8a8a-4797-93e2-c8f582cbdae124
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCDd21f3055-8a8a-4797-93e2-c8f582cbdae124
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSYd21f3055-8a8a-4797-93e2-c8f582cbdae124
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSYd21f3055-8a8a-4797-93e2-c8f582cbdae124
309696dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNdff598e8-e662-411f-978d-4ba3fb8ef7db8
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSNdff598e8-e662-411f-978d-4ba3fb8ef7db8
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNdff598e8-e662-411f-978d-4ba3fb8ef7db8
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCDdff598e8-e662-411f-978d-4ba3fb8ef7db8
309696dexamethasone phosphate 10 MG/ML Injectable SolutionSCDdff598e8-e662-411f-978d-4ba3fb8ef7db8
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCDdff598e8-e662-411f-978d-4ba3fb8ef7db8
309696dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable SolutionSYdff598e8-e662-411f-978d-4ba3fb8ef7db8
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSYdff598e8-e662-411f-978d-4ba3fb8ef7db8
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSYdff598e8-e662-411f-978d-4ba3fb8ef7db8
309696dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN36854dbc-22f2-5df9-e063-6394a90ad9342
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSN36854dbc-22f2-5df9-e063-6394a90ad9342
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN86091483-2053-5da8-e053-2a91aa0a6f452
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN42c879cc-38dc-c9bc-e063-6294a90a204d2
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN36854dbc-22f2-5df9-e063-6394a90ad9342
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCD36854dbc-22f2-5df9-e063-6394a90ad9342
309696dexamethasone phosphate 10 MG/ML Injectable SolutionSCD36854dbc-22f2-5df9-e063-6394a90ad9342
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD86091483-2053-5da8-e053-2a91aa0a6f452
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD42c879cc-38dc-c9bc-e063-6294a90a204d2
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD36854dbc-22f2-5df9-e063-6394a90ad9342
309696dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable SolutionSY36854dbc-22f2-5df9-e063-6394a90ad9342
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY36854dbc-22f2-5df9-e063-6394a90ad9342
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY42c879cc-38dc-c9bc-e063-6294a90a204d2
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY86091483-2053-5da8-e053-2a91aa0a6f452
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSY36854dbc-22f2-5df9-e063-6394a90ad9342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-422-00674570422005 mL in 1 VIAL5 mlHistorical
67457-422-546745704225425 VIAL in 1 CARTON (67457-422-54) / 5 mL in 1 VIAL (67457-422-00) 25 vial2011-05-110000-00-00NoNoCurrent