FDA.reportPublic FDA data

Dexamethasone sodium phosphate

Product NDC
42571-432
11-digit product format
425710432
Labeler code
42571
Product ID
42571-432_1a872893-685a-0bd2-e063-6394a90ae1ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone sodium phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Micro Labs Limited
Application
ANDA217797
Marketing category
ANDA
Marketing start
2024-06-01
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
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 PHOSPHATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAI9376Y64P
Rxcui1812079

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
42571-432-54Dexamethasone sodium phosphate1 mL in 1 VIALINJECTION, SOLUTION12
42571-432-79Dexamethasone sodium phosphate25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-432DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) INJECTION, SOLUTION [MICRO LABS LIMITED]2Current NDC, 2 package rows20240612_c6f2563b-5a39-48bf-bcfe-71dd417bd970.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812079dexAMETHasone sodium phosphate 10 MG in 1 ML InjectionPSNc6f2563b-5a39-48bf-bcfe-71dd417bd9702
18120791 ML dexamethasone phosphate 10 MG/ML InjectionSCDc6f2563b-5a39-48bf-bcfe-71dd417bd9702
1812079dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML InjectionSYc6f2563b-5a39-48bf-bcfe-71dd417bd9702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42571-432-54425710432541 mL in 1 VIAL1 mlHistorical
42571-432-794257104327925 VIAL in 1 CARTON (42571-432-79) / 1 mL in 1 VIAL (42571-432-54) 25 vial2024-06-01NoNoCurrent