NDC 50066-923

GENOZOL

Esomeprazole Magnesium

GENOZOL is a Oral Capsule, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Genomma Lab Usa Inc. The primary component is Esomeprazole Magnesium Dihydrate.

• Product ID: 50066-923_2a857d32-6752-4c03-b974-89417d192745
• NDC: 50066-923
• Product Type: Human Otc Drug
• Proprietary Name: GENOZOL
• Generic Name: Esomeprazole Magnesium
• Dosage Form: Capsule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-10-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209339
• Labeler Name: Genomma Lab USA Inc
• Substance Name: ESOMEPRAZOLE MAGNESIUM DIHYDRATE
• Active Ingredient Strength: 20 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50066-923-05

1 BOTTLE in 1 CARTON (50066-923-05) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

• Marketing Start Date: 2017-10-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50066-923-03 [50066092303]

GENOZOL CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209339
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-10-16
• Marketing End Date: 2019-11-22

NDC 50066-923-05 [50066092305]

GENOZOL CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209339
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-10-16

Drug Details

Active Ingredients

Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE	20 mg/1

NDC Crossover Matching brand name "GENOZOL" or generic name "Esomeprazole Magnesium"

NDC	Brand Name	Generic Name
50066-923	GENOZOL	GENOZOL
50066-915	Genozol	Genozol
0093-6450	Esomeprazole Magnesium	Esomeprazole Magnesium
0093-6451	Esomeprazole Magnesium	Esomeprazole Magnesium
0186-0382	Esomeprazole magnesium	Esomeprazole magnesium
0186-0384	Esomeprazole magnesium	Esomeprazole magnesium
0186-4010	NEXIUM	Esomeprazole magnesium
0186-4020	NEXIUM	Esomeprazole magnesium
0186-4025	NEXIUM	Esomeprazole magnesium