FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
72572-122
11-digit product format
725720122
Labeler code
72572
Product ID
72572-122_e58e43a9-adf9-4243-88a8-7341b5fb2889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA087702
Marketing category
ANDA
Marketing start
2019-11-13
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, 1116927

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
72572-122-01Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION13
72572-122-25Dexamethasone Sodium Phosphate25 in 1 CARTONINJECTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-122-01ML - Milliliter72572-1222dcde18a-e0ee-4e3a-a7b7-f4a0f142f52312019-12-10
72572-122-25ML - Milliliter72572-122717c20aa-54da-4821-b1b2-10f5076acf9c12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-122DEXAMETHASONE SODIUM PHOSPHATE INJECTION [CIVICA, INC.]3Current NDC, Legacy NDC, 2 package rows20241228_d54a27f2-2af8-4f86-a7fd-453f6b1a9997.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309696dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNd54a27f2-2af8-4f86-a7fd-453f6b1a99973
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNd54a27f2-2af8-4f86-a7fd-453f6b1a99973
309696dexamethasone phosphate 10 MG/ML Injectable SolutionSCDd54a27f2-2af8-4f86-a7fd-453f6b1a99973
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCDd54a27f2-2af8-4f86-a7fd-453f6b1a99973
309696dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable SolutionSYd54a27f2-2af8-4f86-a7fd-453f6b1a99973
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSYd54a27f2-2af8-4f86-a7fd-453f6b1a99973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-122-01725720122011 mL in 1 VIAL1 mlHistorical
72572-122-257257201222525 VIAL in 1 CARTON (72572-122-25) / 1 mL in 1 VIAL (72572-122-01) 25 vial2019-11-130000-00-00NoNoCurrent