NDC 57465-100

Estomarol

Aluminum Hydroxide, Bismuth Subcarbonate, Calcium Carbonate, Magnesium Carbonate, Sodium Bicarbonate

Estomarol is a Oral Powder in the Human Otc Drug category. It is labeled and distributed by Laboratorios Imperiales, S.a. De C.v.. The primary component is Aluminum Hydroxide; Bismuth Subcarbonate; Calcium Carbonate; Magnesium Carbonate; Sodium Bicarbonate.

• Product ID: 57465-100_9a73c6d0-db6a-8a66-e053-2995a90a6db6
• NDC: 57465-100
• Product Type: Human Otc Drug
• Proprietary Name: Estomarol
• Generic Name: Aluminum Hydroxide, Bismuth Subcarbonate, Calcium Carbonate, Magnesium Carbonate, Sodium Bicarbonate
• Dosage Form: Powder
• Route of Administration: ORAL
• Marketing Start Date: 2011-05-11
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part331
• Labeler Name: Laboratorios Imperiales, S.A. de C.V.
• Substance Name: ALUMINUM HYDROXIDE; BISMUTH SUBCARBONATE; CALCIUM CARBONATE; MAGNESIUM CARBONATE; SODIUM BICARBONATE
• Active Ingredient Strength: 0 g/3.5g; g/3.5g; g/3.5g; g/3.5g; g/3.5g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 57465-100-00

15 PACKET in 1 BOX (57465-100-00) > 3.5 g in 1 PACKET

• Marketing Start Date: 2011-05-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57465-100-00 [57465010000]

Estomarol POWDER

• Marketing Category: OTC monograph final
• Application Number: part331
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-05-11
• Inactivation Date: 2019-11-13
• Reactivation Date: 2019-12-24

Drug Details

Active Ingredients

Ingredient	Strength
ALUMINUM HYDROXIDE	.18 g/3.5g

OpenFDA Data

• SPL SET ID: 7a1bc8d6-ce04-4ee6-bfa8-7fe087155975
• Manufacturer:
  • Laboratorios Imperiales, S.A. de C.V.
• UNII:
  • 8MDF5V39QO
  • M41L2IN55T
  • 0E53J927NA
  • H0G9379FGK
  • 5QB0T2IUN0