NDC 54348-797

SUPRAX

Cefixime

SUPRAX is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pharmpak, Inc.. The primary component is Cefixime.

• Product ID: 54348-797_8f89a40f-a223-610f-e053-2a95a90ac727
• NDC: 54348-797
• Product Type: Human Prescription Drug
• Proprietary Name: SUPRAX
• Generic Name: Cefixime
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2019-07-12
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065130
• Labeler Name: PharmPak, Inc.
• Substance Name: CEFIXIME
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54348-797-01

1 BOTTLE in 1 BOX (54348-797-01) > 1 CAPSULE in 1 BOTTLE

• Marketing Start Date: 2019-07-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54348-797-01 [54348079701]

SUPRAX CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA065130
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-12

Drug Details

Active Ingredients

Ingredient	Strength
CEFIXIME	400 mg/1

OpenFDA Data

• SPL SET ID: 3ba1c63c-64d9-4df9-ad62-61d4a9661218
• Manufacturer:
  • PharmPak, Inc.
• UNII:
  • 97I1C92E55

Pharmacological Class

• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]
• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]

NDC Crossover Matching brand name "SUPRAX" or generic name "Cefixime"

NDC	Brand Name	Generic Name
27437-201	SUPRAX	cefixime
27437-203	SUPRAX	cefixime
27437-205	SUPRAX	cefixime
27437-206	SUPRAX	cefixime
27437-207	SUPRAX	cefixime
27437-208	SUPRAX	cefixime
43063-537	SUPRAX	cefixime
54348-797	SUPRAX	CEFIXIME
68180-202	SUPRAX	SUPRAX
70518-1020	SUPRAX	SUPRAX
70934-079	SUPRAX	SUPRAX
70518-2006	SUPRAX	SUPRAX
16714-766	Cefixime	cefixime
16714-767	Cefixime	cefixime
43598-673	Cefixime	Cefixime
43598-674	Cefixime	Cefixime
62250-663	Cefixime	cefixime
62250-664	Cefixime	cefixime