FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
0641-6145
11-digit product format
006416145
Labeler code
0641
Product ID
0641-6145_02bf3273-f0c8-448c-9f74-eb009fee9299
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA084282
Marketing category
ANDA
Marketing start
1975-07-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexamethasone Sodium Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE SODIUM PHOSPHATE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAI9376Y64P
Rxcui309696, 1116927, 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
0641-6145-01Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION121
0641-6145-25Dexamethasone Sodium Phosphate25 in 1 CARTONINJECTION2521

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6145-01ML - Milliliter0641-614524b67700-181d-49f7-a823-888fc80b92e912017-03-06
0641-6145-25ML - Milliliter0641-61457721d930-5465-4c7c-88b1-13be9ed1bd2f12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGADEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
WATERINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6145DEXAMETHASONE SODIUM PHOSPHATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]20Current NDC, Legacy NDC, 2 package rows20240606_0277cc0a-2fd4-4605-a310-b613be84ee26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309696dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN0277cc0a-2fd4-4605-a310-b613be84ee2621
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSN0277cc0a-2fd4-4605-a310-b613be84ee2621
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN0277cc0a-2fd4-4605-a310-b613be84ee2621
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCD0277cc0a-2fd4-4605-a310-b613be84ee2621
309696dexamethasone phosphate 10 MG/ML Injectable SolutionSCD0277cc0a-2fd4-4605-a310-b613be84ee2621
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD0277cc0a-2fd4-4605-a310-b613be84ee2621
309696dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable SolutionSY0277cc0a-2fd4-4605-a310-b613be84ee2621
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY0277cc0a-2fd4-4605-a310-b613be84ee2621
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSY0277cc0a-2fd4-4605-a310-b613be84ee2621
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSN1596a3b4-8c2c-41b4-b1eb-af09863eaa136
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCD1596a3b4-8c2c-41b4-b1eb-af09863eaa136
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSY1596a3b4-8c2c-41b4-b1eb-af09863eaa136
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN8969803e-2e45-1f28-e053-2995a90a05a72
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD8969803e-2e45-1f28-e053-2995a90a05a72
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY8969803e-2e45-1f28-e053-2995a90a05a72
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSN2d96d5e8-00bf-406b-b345-f1c31865fe941
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCD2d96d5e8-00bf-406b-b345-f1c31865fe941
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSY2d96d5e8-00bf-406b-b345-f1c31865fe941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6145-01006416145011 mL in 1 VIAL1 mlHistorical
0641-6145-250064161452525 VIAL in 1 CARTON (0641-6145-25) / 1 mL in 1 VIAL (0641-6145-01) 25 vial1975-07-150000-00-00NoNoCurrent