Meloxicam (Page 8 of 8)

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.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL (PDP FOR MELOXICAM 7.5 MG AND 15 MG)

NDC 61442-126-30

Meloxicam

Tablets, USP

7.5 mg

Rx Only

ATTENTION DISPENSER:

Accompanying Medication Guide must be dispensed with this product.

Carlsbad Technology, Inc.

30 Tablets

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 61442-126-01

Meloxicam

Tablets, USP

7.5 mg

Rx Only

ATTENTON DISPENSER:

Accompanying Medication Guide must be dispensed with this product.

Carlsbad Technology, Inc.

100 Tablets

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 61442-126-10

Meloxicam

Tablets, USP

7.5 mg

Rx Only

ATTENTION DISPENSER:

Accompanying Medication Guide must be dispensed with this product.

Carlsbad Technology, Inc.

1000 Tablets

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 61422-127-30

Meloxicam

Tablets, USP

15 mg

Rx Only

ATTENTION DISPENSER:

Accompanying Medication Guide must be dispensed with this product.

Carlsbad Technology, Inc.

30 Tablets

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 61422-127-01

Meloxicam

Tablets, USP

15 mg

Rx Only

ATTENTION DISPENSER:

Accompanying Medication Guide must be dispensed with this product.

Carlsbad Technology, Inc.

100 Tablets

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 61422-127-10

Meloxicam

Tablets, USP

15 mg

Rx Only

ATTENTION DISPENSER:

Accompanying Medication Guide must be dispensed with this product.

Carlsbad Technology, Inc.

1000 Tablets

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL
(click image for full-size original)
MELOXICAM meloxicam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61442-126
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELOXICAM (MELOXICAM) MELOXICAM 7.5 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM CITRATE
Product Characteristics
Color yellow (YELLOW) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code 5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61442-126-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:61442-126-10 1000 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:61442-126-01 100 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
MELOXICAM meloxicam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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
SODIUM STARCH GLYCOLATE TYPE A POTATO
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM CITRATE
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:61442-127-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:61442-127-10 1000 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:61442-127-01 100 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 — Carlsbad Technology, Inc. (781047246)
Registrant — Yung Shin Pharmaceutical Industrual Co., Ltd. (656108149)
Establishment
Name Address ID/FEI Operations
Yung Shin Pharmaceutical Industrial Co., Ltd. 658843289 manufacture (61442-126), pack (61442-126), label (61442-126), manufacture (61442-127), pack (61442-127), label (61442-127)

Revised: 02/2023 Carlsbad Technology, Inc.

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