Prescription Drug Information: Meloxicam (Page 6 of 6)

11 DESCRIPTION

Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam Tablets, USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N -(5-methyl-2-thiazolyl)-2 H -1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14 H 13 N 3 O 4 S 2 and it has the following structural formula:

Structural Formula

Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app = 0.1 in n -octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2.

Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam.

The inactive ingredients in Meloxicam Tablets, USP include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate.

PRINCIPAL DISPLAY PANEL

Meloxicam

Tablets, USP

15 mg

Rx Only

ATTENTION DISPENSER:

Accompanying Medication Guide mustbe dispensed with this product.

image
(click image for full-size original)
MELOXICAM meloxicam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-396(NDC:61442-127)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELOXICAM (MELOXICAM) MELOXICAM 15 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM CITRATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color yellow (YELLOW) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code 100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-396-07 7 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43063-396-15 15 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:43063-396-30 30 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:43063-396-60 60 TABLET in 1 BOTTLE, PLASTIC None
5 NDC:43063-396-90 90 TABLET in 1 BOTTLE, PLASTIC None
6 NDC:43063-396-95 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077918 06/30/2010
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-396)

Revised: 12/2023 PD-Rx Pharmaceuticals, Inc.

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