FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
76045-106
11-digit product format
760450106
Labeler code
76045
Product ID
76045-106_f5934e17-4553-425b-b1bf-140cba479c36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler
Fresenius Kabi USA, LLC
Application
ANDA203129
Marketing category
ANDA
Marketing start
2015-10-30
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
Rxcui1812095

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
76045-106-10Dexamethasone Sodium Phosphate1 in 1 BLISTER PACKINJECTION, SOLUTION114
76045-106-10Dexamethasone Sodium Phosphate24 in 1 CARTONINJECTION, SOLUTION2414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76045-106-10ML - Milliliter76045-1061d276940-4a2c-4c35-abf5-cc5c5d9ce50e12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dexamethasone Sodium PhosphateACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [BD RX INC.]7
DexamethasoneACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [BD RX INC.]7
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [BD RX INC.]7
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [BD RX INC.]7
Trisodium citrate DihydrateINACTIVE INGREDIENTB22547B95KDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [BD RX INC.]7
WaterINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [BD RX INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76045-106DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]13Current NDC, Legacy NDC, 2 package rows20210124_88d25d19-acff-477b-86c8-9797782045b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812095dexAMETHasone sodium phosphate 4 MG in 1 ML Prefilled SyringePSN88d25d19-acff-477b-86c8-9797782045b814
18120951 ML dexamethasone phosphate 4 MG/ML Prefilled SyringeSCD88d25d19-acff-477b-86c8-9797782045b814
1812095dexamethasone phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML Prefilled SyringeSY88d25d19-acff-477b-86c8-9797782045b814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76045-106-107604501061024 BLISTER PACK in 1 CARTON (76045-106-10) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS24 blister pack2015-10-300000-00-00NoNoCurrent