FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
70069-022
11-digit product format
700690022
Labeler code
70069
Product ID
70069-022_733ed212-43c3-4b74-923a-cf0f24689c83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler
Somerset Therapeutics, LLC
Application
ANDA207521
Marketing category
ANDA
Marketing start
2018-06-08
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
Rxcui1116927, 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-022-01Dexamethasone Sodium Phosphate1 mL in 1 VIAL, SINGLE-DOSEINJECTION16
70069-022-25Dexamethasone Sodium Phosphate25 in 1 CARTONINJECTION256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-022DEXAMETHASONE SODIUM PHOSPHATE INJECTION [SOMERSET THERAPEUTICS, LLC]6Current NDC, Legacy NDC, 2 package rows20250112_2dcbf312-6f4b-439a-8e2f-dda61eeb2cab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSN2dcbf312-6f4b-439a-8e2f-dda61eeb2cab6
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN2dcbf312-6f4b-439a-8e2f-dda61eeb2cab6
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCD2dcbf312-6f4b-439a-8e2f-dda61eeb2cab6
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD2dcbf312-6f4b-439a-8e2f-dda61eeb2cab6
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY2dcbf312-6f4b-439a-8e2f-dda61eeb2cab6
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSY2dcbf312-6f4b-439a-8e2f-dda61eeb2cab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-022-01700690022011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
70069-022-257006900222525 VIAL, SINGLE-DOSE in 1 CARTON (70069-022-25) / 1 mL in 1 VIAL, SINGLE-DOSE (70069-022-01) 2018-06-080000-00-00NoNoCurrent