FDA.reportPublic FDA data

DEXAMETHASONE SODIUM PHOSPHATE

Product NDC
70069-025
11-digit product format
700690025
Labeler code
70069
Product ID
70069-025_0fefe630-0e29-4d04-a083-eb3036f48100
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXAMETHASONE SODIUM PHOSPHATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA211036
Marketing category
ANDA
Marketing start
2019-06-11
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
Rxcui309696

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
70069-025-10DEXAMETHASONE SODIUM PHOSPHATE10 in 1 CARTONINJECTION, SOLUTION109
70069-025-10DEXAMETHASONE SODIUM PHOSPHATE10 mL in 1 VIALINJECTION, SOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-025-01ML - Milliliter70069-025f59a99dc-b166-4a05-a22d-dc1f58e0bab712019-09-05
70069-025-10ML - Milliliter70069-025e4e08e77-c213-46f1-aa24-ff015ea2a57c12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-025DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]9Current NDC, Legacy NDC, 2 package rows20250216_5a1b0266-90c8-4176-a6b0-c4204d3c604e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309696dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN5a1b0266-90c8-4176-a6b0-c4204d3c604e9
309696dexamethasone phosphate 10 MG/ML Injectable SolutionSCD5a1b0266-90c8-4176-a6b0-c4204d3c604e9
309696dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable SolutionSY5a1b0266-90c8-4176-a6b0-c4204d3c604e9
309696dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN9f69846e-5897-c301-e053-2a95a90a44f15
309696dexamethasone phosphate 10 MG/ML Injectable SolutionSCD9f69846e-5897-c301-e053-2a95a90a44f15
309696dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable SolutionSY9f69846e-5897-c301-e053-2a95a90a44f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-025-107006900251010 VIAL in 1 CARTON (70069-025-10) / 10 mL in 1 VIAL10 vial2019-06-110000-00-00NoNoCurrent