FDA.reportPublic FDA data

DEXAMETHASONE SODIUM PHOSPHATE

Product NDC
51662-1541
11-digit product format
516621541
Labeler code
51662
Product ID
51662-1541_23fe0621-df52-99d3-e063-6394a90a44e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXAMETHASONE SODIUM PHOSPHATE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA210967
Marketing category
ANDA
Marketing start
2022-05-20
Substance
DEXAMETHASONE SODIUM PHOSPHATE
Active strength
100 mg/10mL
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 PHOSPHATE100 mg/10mL

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
51662-1541-1DEXAMETHASONE SODIUM PHOSPHATE10 mL in 1 VIALINJECTION106
51662-1541-2DEXAMETHASONE SODIUM PHOSPHATE1 in 1 POUCHINJECTION16
51662-1541-3DEXAMETHASONE SODIUM PHOSPHATE10 in 1 CASEINJECTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1541DEXAMETHASONE SODIUM PHOSPHATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]6Current NDC, Legacy NDC, 3 package rows20241010_df77fab1-f58c-46db-e053-2a95a90a5416.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309696dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNdf77fab1-f58c-46db-e053-2a95a90a54166
309696dexamethasone phosphate 10 MG/ML Injectable SolutionSCDdf77fab1-f58c-46db-e053-2a95a90a54166
309696dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable SolutionSYdf77fab1-f58c-46db-e053-2a95a90a54166

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1541-15166215410110 mL in 1 VIAL (51662-1541-1) 10 ml2022-05-200000-00-00NoNoCurrent
51662-1541-2516621541021 in 1 POUCHHistorical
51662-1541-35166215410310 POUCH in 1 CASE (51662-1541-3) / 1 VIAL in 1 POUCH (51662-1541-2) / 10 mL in 1 VIAL (51662-1541-1) 10 pouch2022-05-20NoNoCurrent