Meloxicam
These highlights do not include all the information needed to use Meloxicam Tablets, USP safely and effectively. See full prescribing information for Meloxicam Tablets, USP. Meloxicam Tablets, USPInitial U.S. Approval: 2000
Approved
Approval ID
8b2aa351-4ac3-4b5f-a20c-060805812cd0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2014
Manufacturers
FDA
ReadyMeds
DUNS: 072115132
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Meloxicam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64205-126
Application NumberANDA077918
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2014
FDA Product Classification
INGREDIENTS (8)
LactoseInactive
Code: J2B2A4N98G
Classification: IACT
MeloxicamActive
Quantity: 7.5 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Colloidal Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Sodium CitrateInactive
Code: 1Q73Q2JULR
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Povidone K30Inactive
Code: U725QWY32X
Classification: IACT
Meloxicam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64205-127
Application NumberANDA077918
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2014
FDA Product Classification
INGREDIENTS (8)
Colloidal Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
MeloxicamActive
Quantity: 15 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LactoseInactive
Code: J2B2A4N98G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Sodium CitrateInactive
Code: 1Q73Q2JULR
Classification: IACT
Povidone K30Inactive
Code: U725QWY32X
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 7/1/2014