MELOXICAM
These highlights do not include all the information needed to use MELOXICAM TABLETS safely and effectively. See full prescribing information for MELOXICAM TABLETS.
Approved
Approval ID
5bce27c7-c5c3-46f6-9327-321f1e81aa27
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2023
Manufacturers
FDA
Ascent Pharmaceuticals, Inc
DUNS: 080938961
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 Code43602-624
Application NumberANDA217579
Product Classification
M
Marketing Category
C73584
G
Generic Name
meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2023
FDA Product Classification
INGREDIENTS (7)
MELOXICAMActive
Quantity: 15 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
meloxicam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-623
Application NumberANDA217579
Product Classification
M
Marketing Category
C73584
G
Generic Name
meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2023
FDA Product Classification
INGREDIENTS (7)
MELOXICAMActive
Quantity: 7.5 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Drug Labeling Information
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 5/19/2023
RECENT MAJOR CHANGES
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms (5.10) 04/2021
Warnings and Precautions, Fetal Toxicity (5.11) 04/2021