52125-035 : Smx 800 mg / Tmp 160 mg Oral Tablet

NDC:	52125-035
Labeler:	Remedyrepack Inc.
Product Type:	Human Prescription Drug
Drug Name:	Sulfamethoxazole and Trimethoprim
Dosage Form:	Oral Tablet
Application #:	ANDA078060
Rev. Date:	Feb 26, 2013

Appearance:

Markings:	5898;V
Shapes:	Oval
Colors:	White
Size (mm):	19
Segments: *	2
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

• 52125-035-02: 30 TABLET IN 1 BLISTER PACK (52125‑035‑02)

Active Ingredients:

• Sulfamethoxazole

Inactive Ingredients:

• Hypromelloses
• Lactose Monohydrate
• Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
• Cellulose, Microcrystalline
• Talc
• Triethyl Citrate
• Fd&c Blue No. 2
• Fd&c Red No. 40
• Fd&c Yellow No. 6
• Docusate Sodium
• Magnesium Stearate
• Povidones
• Starch, Corn
• Sodium Benzoate
• Sodium Starch Glycolate Type a Potato

Pharmaceutical Classes:

• Sulfonamide Antimicrobial [EPC]
• Sulfonamides [Chemical/Ingredient]
• Cytochrome P450 2C9 Inhibitors [MoA]

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