NDC 53041-663

Omeprazole, Sodium bicarbonate

Omeprazole, Sodium Bicarbonate

Omeprazole, Sodium bicarbonate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Guardian Drug Company. The primary component is Omeprazole; Sodium Bicarbonate.

• Product ID: 53041-663_27536955-37df-4dcc-ad75-2b364fe95460
• NDC: 53041-663
• Product Type: Human Prescription Drug
• Proprietary Name: Omeprazole, Sodium bicarbonate
• Generic Name: Omeprazole, Sodium Bicarbonate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2020-05-07
• Marketing Category: ANDA / ANDA
• Application Number: ANDA212587
• Labeler Name: Guardian Drug Company
• Substance Name: OMEPRAZOLE; SODIUM BICARBONATE
• Active Ingredient Strength: 40 mg/1; mg/1
• Pharm Classes: Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 53041-663-77

30 CAPSULE in 1 BOTTLE (53041-663-77)

• Marketing Start Date: 2020-05-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53041-663-77 [53041066377]

Omeprazole, Sodium bicarbonate CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA212587
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-05-07

Drug Details

Active Ingredients

Ingredient	Strength
OMEPRAZOLE	40 mg/1

NDC Crossover Matching brand name "Omeprazole, Sodium bicarbonate" or generic name "Omeprazole, Sodium Bicarbonate"

NDC	Brand Name	Generic Name
53041-663	Omeprazole, Sodium bicarbonate	Omeprazole, Sodium bicarbonate
53041-664	Omeprazole, Sodium bicarbonate	Omeprazole, Sodium bicarbonate
63629-2490	Omeprazole, Sodium bicarbonate	Omeprazole, Sodium bicarbonate
63629-2491	Omeprazole, Sodium bicarbonate	Omeprazole, Sodium bicarbonate
0113-0058	Good Sense Omeprazole and Sodium Bicarbonate	Omeprazole, sodium bicarbonate
0363-0732	Omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate
37808-732	Omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate
41250-938	omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate
59779-732	Omeprazole and Sodium Bicarbonate	Omeprazole, sodium bicarbonate
68682-102	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate
68682-104	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate
66993-412	omeprazole/sodium bicarbonate	omeprazole, sodium bicarbonate
66993-413	omeprazole/sodium bicarbonate	omeprazole, sodium bicarbonate
36800-732	topcare omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate