FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
68083-607
11-digit product format
680830607
Labeler code
68083
Product ID
68083-607_0ca8b553-e90b-4049-8c44-35b876d8f186
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler
Gland Pharma Limited
Application
ANDA215654
Marketing category
ANDA
Marketing start
2023-09-25
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
Rxcui1116927, 1812079, 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
68083-607-01Dexamethasone Sodium Phosphate1 mL in 1 VIAL, SINGLE-DOSEINJECTION17
68083-607-25Dexamethasone Sodium Phosphate25 in 1 CARTONINJECTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-607DEXAMETHASONE SODIUM PHOSPHATE INJECTION [GLAND PHARMA LIMITED]7Current NDC, 2 package rows20240705_c9d9ab76-6bc6-433d-aad7-8d49064ed745.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812079dexAMETHasone sodium phosphate 10 MG in 1 ML InjectionPSNc9d9ab76-6bc6-433d-aad7-8d49064ed7457
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSNc9d9ab76-6bc6-433d-aad7-8d49064ed7457
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNc9d9ab76-6bc6-433d-aad7-8d49064ed7457
18120791 ML dexamethasone phosphate 10 MG/ML InjectionSCDc9d9ab76-6bc6-433d-aad7-8d49064ed7457
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCDc9d9ab76-6bc6-433d-aad7-8d49064ed7457
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCDc9d9ab76-6bc6-433d-aad7-8d49064ed7457
1812079dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML InjectionSYc9d9ab76-6bc6-433d-aad7-8d49064ed7457
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSYc9d9ab76-6bc6-433d-aad7-8d49064ed7457
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSYc9d9ab76-6bc6-433d-aad7-8d49064ed7457

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-607-01680830607011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
68083-607-256808306072525 VIAL, SINGLE-DOSE in 1 CARTON (68083-607-25) / 1 mL in 1 VIAL, SINGLE-DOSE (68083-607-01) 2023-09-25NoNoCurrent