FDA.reportPublic FDA data

Dexamethasone Sodium Phosphate

Product NDC
63323-165
11-digit product format
633230165
Labeler code
63323
Product ID
63323-165_9dd90418-e564-4bc5-9077-506a1c2c1bce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXAMETHASONE SODIUM PHOSPHATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA084916
Marketing category
ANDA
Marketing start
2000-09-07
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
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 PHOSPHATE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAI9376Y64P
Rxcui1116927, 1812194

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
a831e694-3663-4a83-82be-6c309429f750Product name220200608
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct 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
63323-165-01Dexamethasone Sodium Phosphate25 in 1 TRAYINJECTION, SOLUTION256
63323-165-02Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION, SOLUTION16
63323-165-03Dexamethasone Sodium Phosphate5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION56
63323-165-05Dexamethasone Sodium Phosphate25 in 1 TRAYINJECTION, SOLUTION256
63323-165-11Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION, SOLUTION16
63323-165-13Dexamethasone Sodium Phosphate5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION56
63323-165-30Dexamethasone Sodium Phosphate30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION306
63323-165-30Dexamethasone Sodium Phosphate1 in 1 BOXINJECTION, SOLUTION16
63323-165-51Dexamethasone Sodium Phosphate25 in 1 TRAYINJECTION, SOLUTION256
63323-165-53Dexamethasone Sodium Phosphate25 in 1 TRAYINJECTION, SOLUTION256
63323-165-16Dexamethasone Sodium Phosphate25 in 1 TRAYINJECTION, SOLUTION253
63323-165-16Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION, SOLUTION13
63323-165-26Dexamethasone Sodium Phosphate5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION53
63323-165-26Dexamethasone Sodium Phosphate25 in 1 TRAYINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-165-01ML - Milliliter63323-1656e55c862-8987-4ecc-afdf-cad7b61b3eb212012-07-24
63323-165-02ML - Milliliter63323-16538751704-0982-48a7-b8bf-53f9c59ee7a912018-07-03
63323-165-03ML - Milliliter63323-165ed621c97-a49f-4003-a974-a4568f47123c12018-07-03
63323-165-05ML - Milliliter63323-1653c40a72c-671a-4d8a-9dfa-08dca3e814aa12012-07-24
63323-165-16ML - Milliliter63323-16587515e12-3d2d-464e-bc28-2538e57da22412015-12-02
63323-165-26ML - Milliliter63323-165bf356dfa-c1e8-45bf-9a23-bf3d1b08a1b812015-12-02
63323-165-30ML - Milliliter63323-16569e24d2d-3cee-4ab7-ba96-806aa053bfa212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-165DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 10 package rows20240915_2b626a48-c7aa-4443-9164-a08ff069ccd1.zip
63323-165DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 4 package rows20241019_4fedef4f-ec96-4f36-b2f0-01e243e3b89e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN3c05089c-5a25-40c3-9abc-b2e40696bcdc19
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD3c05089c-5a25-40c3-9abc-b2e40696bcdc19
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY3c05089c-5a25-40c3-9abc-b2e40696bcdc19
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN6d3cbd54-93ef-40fe-b15a-7a4f52dc5f7112
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD6d3cbd54-93ef-40fe-b15a-7a4f52dc5f7112
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY6d3cbd54-93ef-40fe-b15a-7a4f52dc5f7112
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNa928b3ca-2408-425e-9dda-1ef84243d56c10
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCDa928b3ca-2408-425e-9dda-1ef84243d56c10
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSYa928b3ca-2408-425e-9dda-1ef84243d56c10
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSN2b626a48-c7aa-4443-9164-a08ff069ccd16
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN2b626a48-c7aa-4443-9164-a08ff069ccd16
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCD2b626a48-c7aa-4443-9164-a08ff069ccd16
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD2b626a48-c7aa-4443-9164-a08ff069ccd16
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY2b626a48-c7aa-4443-9164-a08ff069ccd16
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSY2b626a48-c7aa-4443-9164-a08ff069ccd16
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSN84fffebe-8468-42be-adab-6220e737499a4
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN84fffebe-8468-42be-adab-6220e737499a4
797544isopropyl alcohol 70 % Medicated PadPSN84fffebe-8468-42be-adab-6220e737499a4
2480108Kenalog 40 MG in 1 ML InjectionPSN84fffebe-8468-42be-adab-6220e737499a4
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSN84fffebe-8468-42be-adab-6220e737499a4
24801081 ML triamcinolone acetonide 40 MG/ML Injection [Kenalog]SBD84fffebe-8468-42be-adab-6220e737499a4
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCD84fffebe-8468-42be-adab-6220e737499a4
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCD84fffebe-8468-42be-adab-6220e737499a4
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD84fffebe-8468-42be-adab-6220e737499a4
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD84fffebe-8468-42be-adab-6220e737499a4
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY84fffebe-8468-42be-adab-6220e737499a4
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSY84fffebe-8468-42be-adab-6220e737499a4
797544isopropyl alcohol 70 % Medicated PadSY84fffebe-8468-42be-adab-6220e737499a4
797544isopropyl alcohol 70 % Topical ClothSY84fffebe-8468-42be-adab-6220e737499a4
797544isopropyl alcohol 70 % Topical SwabSY84fffebe-8468-42be-adab-6220e737499a4
2480108Kenalog 40 MG per 1 ML InjectionSY84fffebe-8468-42be-adab-6220e737499a4
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSY84fffebe-8468-42be-adab-6220e737499a4
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSNbb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c13
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSN4fedef4f-ec96-4f36-b2f0-01e243e3b89e3
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNbb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c13
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN4fedef4f-ec96-4f36-b2f0-01e243e3b89e3
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN94cb045b-5801-db32-e053-2a95a90a93ef3
797544isopropyl alcohol 70 % Medicated PadPSNbb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c13
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCD4fedef4f-ec96-4f36-b2f0-01e243e3b89e3
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCDbb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c13
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD94cb045b-5801-db32-e053-2a95a90a93ef3
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD4fedef4f-ec96-4f36-b2f0-01e243e3b89e3
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCDbb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c13
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDbb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c13
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY94cb045b-5801-db32-e053-2a95a90a93ef3
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY4fedef4f-ec96-4f36-b2f0-01e243e3b89e3
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSYbb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c13
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSY4fedef4f-ec96-4f36-b2f0-01e243e3b89e3
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSYbb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c13
797544isopropyl alcohol 70 % Medicated PadSYbb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c13
797544isopropyl alcohol 70 % Topical ClothSYbb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c13
797544isopropyl alcohol 70 % Topical SwabSYbb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-165-016332301650125 VIAL in 1 TRAY (63323-165-01) / 1 mL in 1 VIAL (63323-165-02) 25 vial2000-09-070000-00-00NoNoCurrent
63323-165-02633230165021 mL in 1 VIAL1 mlHistorical
63323-165-03633230165035 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
63323-165-056332301650525 VIAL, MULTI-DOSE in 1 TRAY (63323-165-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-03) 2000-09-070000-00-00NoNoCurrent
63323-165-11633230165111 mL in 1 VIAL1 mlHistorical
63323-165-13633230165135 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
63323-165-166332301651625 VIAL in 1 TRAY (63323-165-16) / 1 mL in 1 VIAL25 vial2000-09-070000-00-00NoNoCurrent
63323-165-266332301652625 VIAL, MULTI-DOSE in 1 TRAY (63323-165-26) / 5 mL in 1 VIAL, MULTI-DOSE2000-09-070000-00-00NoNoCurrent
63323-165-30633230165301 VIAL, MULTI-DOSE in 1 BOX (63323-165-30) / 30 mL in 1 VIAL, MULTI-DOSE2000-09-070000-00-00NoNoCurrent
63323-165-516332301655125 VIAL in 1 TRAY (63323-165-51) / 1 mL in 1 VIAL (63323-165-11) 25 vial2025-02-17NoNoCurrent
63323-165-536332301655325 VIAL, MULTI-DOSE in 1 TRAY (63323-165-53) / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-13) 2025-02-17NoNoCurrent