FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
50090-2313
11-digit product format
500902313
Labeler code
50090
Product ID
50090-2313_f4c64697-8e6a-4d2b-a293-3727e2a5e7cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler
A-S Medication Solutions
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
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
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2313-22023-02-07C16284748780-1f386c649-add5-0266-e053-dadaa90a7c1aDexamethasone Sodium Phosphate Injection, USP
50090-2313-32023-02-07C16284748780-1f386c649-add5-0266-e053-dadaa90a7c1aDexamethasone Sodium Phosphate Injection, USP
50090-2313-22023-01-30C16284748780-1f386c649-add5-0266-e053-dadaa90a7c1aDexamethasone Sodium Phosphate Injection, USP
50090-2313-32023-01-30C16284748780-1f386c649-add5-0266-e053-dadaa90a7c1aDexamethasone Sodium Phosphate Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2313-2Dexamethasone Sodium Phosphate5 mL in 1 VIALINJECTION, SOLUTION524
50090-2313-2Dexamethasone Sodium Phosphate2 in 1 CARTONINJECTION, SOLUTION224
50090-2313-3Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION, SOLUTION124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2313DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 3 package rows20240417_d21f3055-8a8a-4797-93e2-c8f582cbdae1.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2313-2500902313022 VIAL in 1 CARTON (50090-2313-2) / 5 mL in 1 VIAL2 vial2016-02-230000-00-00NoNoCurrent
50090-2313-3500902313031 mL in 1 VIAL (50090-2313-3) 1 ml2020-03-270000-00-00NoNoCurrent