Dexamethasone

Product NDC
53217-310
11-digit product format
532170310
Labeler code
53217
Product ID
53217-310_be5921e9-99ec-47c5-af90-5ef03b4e8c33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
ELIXIR
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA084754
Marketing category
ANDA
Marketing start
2017-05-19
Marketing end
0000-00-00
Substance
DEXAMETHASONE
Active strength
1 mg/5mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-310-012020-01-31C16284748780-19d75b9d0-7efd-f424-e053-dadaa90a57ceDEXAMETHASONE ELIXIR, USP 0.5 mg / 5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-310-01Dexamethasone237 mL in 1 BOTTLE, GLASSELIXIR2371

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-310-01ML - Milliliter53217-3102bcb8be3-8c7f-45b4-9b44-69cda3a66c1e12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-310DEXAMETHASONE ELIXIR [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180522_4f6e8fd1-d3c5-46a3-b6ca-0748bfc59030.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309686dexAMETHasone 0.5 MG in 5 mL Oral SolutionPSN4f6e8fd1-d3c5-46a3-b6ca-0748bfc590301
309686dexamethasone 0.1 MG/ML Oral SolutionSCD4f6e8fd1-d3c5-46a3-b6ca-0748bfc590301
309686dexamethasone 0.5 MG per 5 ML Oral SolutionSY4f6e8fd1-d3c5-46a3-b6ca-0748bfc590301
309686dexamethasone 1 MG per 10 ML Oral SolutionSY4f6e8fd1-d3c5-46a3-b6ca-0748bfc590301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-310-0153217031001237 mL in 1 BOTTLE, GLASS237 mlHistorical