Dexamethasone Sodium Phosphate

Product NDC
81565-202
11-digit product format
815650202
Labeler code
81565
Product ID
81565-202_a6657f08-273a-4608-a117-f9aa560d59a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXAMETHASONE SODIUM PHOSPHATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Phlow Corporation
Application
ANDA084916
Marketing category
ANDA
Marketing start
2021-12-15
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
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
Rxcui1812194

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81565-202-022024-02-22C16284748780-11030e365-69e4-111a-e063-dadaa90a10e2Dexamethasone Sodium Phosphate Injection, USP
81565-202-022024-01-30C16284748780-11030e365-69e4-111a-e063-dadaa90a10e2Dexamethasone Sodium Phosphate Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81565-202-01Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION, SOLUTION13
81565-202-02Dexamethasone Sodium Phosphate25 in 1 TRAYINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81565-202-01ML - Milliliter81565-202d4cc6f4d-866e-400a-9c10-2cf1604a187e12022-05-04
81565-202-02ML - Milliliter81565-202b73bdd71-4a09-4d7b-9332-e09f8691f1fb12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81565-202DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) INJECTION, SOLUTION [PHLOW CORPORATION]3Current NDC, Legacy NDC, 2 package rows20240704_02d25ab8-8f51-452b-b944-f569fbae36fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSN02d25ab8-8f51-452b-b944-f569fbae36fe3
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCD02d25ab8-8f51-452b-b944-f569fbae36fe3
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSY02d25ab8-8f51-452b-b944-f569fbae36fe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81565-202-01815650202011 mL in 1 VIAL1 mlHistorical
81565-202-028156502020225 VIAL in 1 TRAY (81565-202-02) / 1 mL in 1 VIAL (81565-202-01) 25 vial2021-12-150000-00-00NoNoCurrent