meloxicam
MELOXICAM TABLETS
Approved
Approval ID
5eb2e439-2ef2-496c-9aec-042029ae1305
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code65841-051
Application NumberANDA077921
Product Classification
M
Marketing Category
C73584
G
Generic Name
meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2022
FDA Product Classification
INGREDIENTS (8)
MELOXICAMActive
Quantity: 15 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
meloxicam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-050
Application NumberANDA077921
Product Classification
M
Marketing Category
C73584
G
Generic Name
meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2022
FDA Product Classification
INGREDIENTS (8)
MELOXICAMActive
Quantity: 7.5 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT