NDC 0597-0315

DUO Fusion

Famotidine, Calcium Carbonate, Magnesium Hydroxide

DUO Fusion is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Famotidine; Calcium Carbonate; Magnesium Hydroxide.

• Product ID: 0597-0315_f8d3d1af-f0af-6e4b-32df-44813c642a46
• NDC: 0597-0315
• Product Type: Human Otc Drug
• Proprietary Name: DUO Fusion
• Generic Name: Famotidine, Calcium Carbonate, Magnesium Hydroxide
• Dosage Form: Tablet, Chewable
• Route of Administration: ORAL
• Marketing Start Date: 2016-03-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077355
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE
• Active Ingredient Strength: 10 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0597-0315-97

20 TABLET, CHEWABLE in 1 BOTTLE (0597-0315-97)

• Marketing Start Date: 2016-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0315-36 [00597031536]

DUO Fusion TABLET, CHEWABLE

• Marketing Category: ANDA
• Application Number: ANDA077355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-03-01
• Inactivation Date: 2020-01-31

NDC 0597-0315-08 [00597031508]

DUO Fusion TABLET, CHEWABLE

• Marketing Category: ANDA
• Application Number: ANDA077355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-03-01
• Inactivation Date: 2020-01-31

NDC 0597-0315-97 [00597031597]

DUO Fusion TABLET, CHEWABLE

• Marketing Category: ANDA
• Application Number: ANDA077355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-03-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
FAMOTIDINE	10 mg/1

OpenFDA Data

• SPL SET ID: 10abaed0-f345-c4e6-70eb-83ae32bf3d8a
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • 5QZO15J2Z8
  • H0G9379FGK
  • NBZ3QY004S
• RxNorm Concept Unique ID - RxCUI:
  • 1744398
  • 283641

NDC Crossover Matching brand name "DUO Fusion" or generic name "Famotidine, Calcium Carbonate, Magnesium Hydroxide"

NDC	Brand Name	Generic Name
0597-0315	DUO Fusion	Famotidine, Calcium carbonate, Magnesium hydroxide
0597-0320	DUO Fusion	Famotidine, Calcium carbonate, Magnesium hydroxide
0363-0713	Acid Reducer Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide
37012-009	Acid Reducer Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide
11822-0223	acid reducer plus antacid	Famotidine, Calcium Carbonate, Magnesium Hydroxide
41520-617	CareOne Acid Reducer Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide
30142-213	Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide
37808-121	Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide
41250-690	Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide
41163-546	equaline complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide
46122-346	Good Neighbor Pharmacy Dual Action Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide
37205-681	leader acid reducer complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide
21130-546	signature care acid reducer complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide
36800-082	topcare dual action complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide
11673-010	up and up famotidine complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide