FDA.reportPublic FDA data

Meloxicam

Product NDC
64205-108
11-digit product format
642050108
Labeler code
64205
Product ID
64205-108_8669fa89-72e1-4ac8-97b4-50a5ca630321
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
ReadyMeds
Application
ANDA077923
Marketing category
ANDA
Marketing start
2012-08-28
Marketing end
0000-00-00
Substance
MELOXICAM
Active strength
15 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bdef11ce-16e2-4690-96a3-597bcf5cc738Product name120260130
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
3e9b4ed6-844c-4725-9d19-cceb5c823572Product name220210903
b21a682e-c765-4e26-9bb2-dbb8c7b38ef7Product name120200623
a428d1db-64d7-4fc3-8d13-832b1e84b683Product name120190201
96649a58-aac8-401c-be00-450b4335f7e7Product name120161116
f0761cb7-8207-3a19-2ca3-ecbb559b04e1Product name220161116

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64205-108-302019-11-27C16284748780-19855e2a2-472b-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use meloxicam tablets safely and effectively. See full prescribing information for meloxicam tablets. Meloxicam Tablets, USP Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64205-108-30Meloxicam30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [READYMEDS]4
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [READYMEDS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [READYMEDS]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMELOXICAM TABLET [READYMEDS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMELOXICAM TABLET [READYMEDS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [READYMEDS]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [READYMEDS]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMELOXICAM TABLET [READYMEDS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64205-108MELOXICAM TABLET [READYMEDS]4Legacy NDC, 1 package rows20140701_a9da4978-be10-4601-a693-7d436c8613b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSNa9da4978-be10-4601-a693-7d436c8613b44
311486meloxicam 7.5 MG Oral TabletPSNa9da4978-be10-4601-a693-7d436c8613b44
152695meloxicam 15 MG Oral TabletSCDa9da4978-be10-4601-a693-7d436c8613b44
311486meloxicam 7.5 MG Oral TabletSCDa9da4978-be10-4601-a693-7d436c8613b44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64205-108-306420501083030 in 1 BOTTLE, PLASTICHistorical