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
NDC Product Code43602-624
Application NumberANDA217579
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 8, 2023
Generic Namemeloxicam
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
NDC Product Code43602-623
Application NumberANDA217579
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 8, 2023
Generic Namemeloxicam
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