NDC 58354-101

Zantanol Tab.

Magnesium Oxide, Magnesium Aluminum Hydrate

Zantanol Tab. is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Cho-a Pharm.co.,ltd.. The primary component is Magnesium Oxide; Magaldrate.

• Product ID: 58354-101_bcdeaf1a-6dcd-4ebe-b50a-b4bc91aa418f
• NDC: 58354-101
• Product Type: Human Otc Drug
• Proprietary Name: Zantanol Tab.
• Generic Name: Magnesium Oxide, Magnesium Aluminum Hydrate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-02-28
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part331
• Labeler Name: Cho-A Pharm.Co.,Ltd.
• Substance Name: MAGNESIUM OXIDE; MAGALDRATE
• Active Ingredient Strength: 50 mg/424mg; mg/424mg
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 58354-101-02

10 CAPSULE in 1 PACKAGE (58354-101-02) > 424 mg in 1 CAPSULE (58354-101-01)

• Marketing Start Date: 2017-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58354-101-02 [58354010102]

Zantanol Tab. TABLET

• Marketing Category: OTC monograph final
• Application Number: part331
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-02-28
• Inactivation Date: 2020-01-31

NDC 58354-101-01 [58354010101]

Zantanol Tab. TABLET

• Marketing Category: OTC monograph final
• Application Number: part331
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-02-28

Drug Details

Active Ingredients

Ingredient	Strength
MAGNESIUM OXIDE	50 mg/424mg

OpenFDA Data

• SPL SET ID: 9b3092fa-86e6-469d-8f73-0626e4c12a28
• Manufacturer:
  • Cho-A Pharm.Co.,Ltd.
• UNII:
  • 3A3U0GI71G
  • 6V88E24N5T

NDC Crossover Matching brand name "Zantanol Tab." or generic name "Magnesium Oxide, Magnesium Aluminum Hydrate"

NDC	Brand Name	Generic Name
58354-101	Zantanol Tab.	MAGNESIUM OXIDE, Magnesium Aluminum Hydrate
58354-120	Zantanol Tab.	MAGNESIUM OXIDE, Magnesium Aluminum Hydrate