NDC 68210-0007

FAMOTIDINE

Famotidine

FAMOTIDINE is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Spirit Pharmaceuticals,llc. The primary component is Famotidine.

• Product ID: 68210-0007_0935b09d-5609-4cc5-a65c-e5da29bc9449
• NDC: 68210-0007
• Product Type: Human Otc Drug
• Proprietary Name: FAMOTIDINE
• Generic Name: Famotidine
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2013-08-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077146
• Labeler Name: SPIRIT PHARMACEUTICALS,LLC
• Substance Name: FAMOTIDINE
• Active Ingredient Strength: 10 mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68210-0007-0

2 BLISTER PACK in 1 CARTON (68210-0007-0) > 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2013-08-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68210-0007-0 [68210000700]

FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA077146
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-08-19
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
FAMOTIDINE	10 mg/1

OpenFDA Data

• SPL SET ID: 84a9a761-7d6f-4e63-814f-e7a71e0ff11b
• Manufacturer:
  • SPIRIT PHARMACEUTICALS,LLC
• UNII:
  • 5QZO15J2Z8

NDC Crossover Matching brand name "FAMOTIDINE" or generic name "Famotidine"

NDC	Brand Name	Generic Name
0093-2748	Famotidine	Famotidine
0172-5728	Famotidine	Famotidine
0172-5729	Famotidine	Famotidine
0338-5197	Famotidine	Famotidine
0363-0036	Famotidine	Famotidine
0363-1899	Famotidine	Famotidine
68001-240	Famotidine	Famotidine
68001-241	Famotidine	Famotidine
68071-1879	Famotidine	Famotidine
68071-3181	Famotidine	Famotidine
68071-1941	Famotidine	Famotidine
68071-3305	Famotidine	Famotidine
68071-4197	Famotidine	Famotidine
68071-3201	Famotidine	Famotidine
68151-0184	Famotidine	Famotidine
68151-0185	Famotidine	Famotidine
68180-150	Famotidine	Famotidine
68210-0007	FAMOTIDINE	FAMOTIDINE
68382-444	Famotidine	Famotidine
68645-140	Famotidine	Famotidine
68645-141	Famotidine	Famotidine
68788-6859	Famotidine	Famotidine
68788-6399	Famotidine	Famotidine
68788-9217	Famotidine	Famotidine
68788-7191	Famotidine	Famotidine
68788-9549	Famotidine	Famotidine
68788-9220	Famotidine	Famotidine
68788-9779	Famotidine	Famotidine
70253-128	Famotidine	Famotidine
70518-0460	Famotidine	Famotidine
70518-0461	Famotidine	Famotidine
70518-0163	Famotidine	Famotidine
70518-1415	Famotidine	Famotidine
70518-1341	Famotidine	Famotidine
70518-1001	Famotidine	Famotidine
70518-1089	Famotidine	Famotidine
70518-1877	Famotidine	Famotidine
71335-0409	Famotidine	Famotidine
0615-4582	Famotidine	Famotidine
71335-0370	Famotidine	Famotidine
0615-4594	Famotidine	Famotidine
72036-026	Famotidine	Famotidine
0641-6023	Famotidine	Famotidine
0641-6022	Famotidine	Famotidine
0641-6021	Famotidine	Famotidine
10544-481	Famotidine	Famotidine
12634-967	Famotidine	Famotidine
15127-370	Famotidine	Famotidine
33261-185	Famotidine	Famotidine
33261-562	Famotidine	Famotidine