NDC 46122-163

Eye Itch Relief

Ketotifen Fumarate

Eye Itch Relief is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Amerisource Bergen. The primary component is Ketotifen Fumarate.

• Product ID: 46122-163_e735287e-92a2-4037-8650-e763c6895af9
• NDC: 46122-163
• Product Type: Human Otc Drug
• Proprietary Name: Eye Itch Relief
• Generic Name: Ketotifen Fumarate
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2013-12-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077958
• Labeler Name: Amerisource Bergen
• Substance Name: KETOTIFEN FUMARATE
• Active Ingredient Strength: 0 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 46122-163-64

1 BOTTLE, DROPPER in 1 CARTON (46122-163-64) > 5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2013-12-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46122-163-64 [46122016364]

Eye Itch Relief SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA077958
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-12-06
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
KETOTIFEN FUMARATE	.35 mg/mL

OpenFDA Data

• SPL SET ID: dbe53fa4-208b-45ee-8245-ec87d6c0cffa
• Manufacturer:
  • Amerisource Bergen
• UNII:
  • HBD503WORO
• RxNorm Concept Unique ID - RxCUI:
  • 311237
• UPC Code:
  • 0087701425493

NDC Crossover Matching brand name "Eye Itch Relief" or generic name "Ketotifen Fumarate"

NDC	Brand Name	Generic Name
0363-0038	Eye Itch Relief	ketotifen fumarate
0363-0610	EYE ITCH RELIEF	Ketotifen Fumarate
0536-1096	Eye Itch Relief	Ketotifen Fumarate
11673-064	Eye Itch Relief	ketotifen fumarate
11822-4201	eye itch relief	ketotifen fumarate
11822-4202	eye itch relief	ketotifen fumarate
21130-601	Eye Itch Relief	Ketotifen Fumarate
68016-403	Eye Itch Relief	Eye Itch Relief
70000-0124	Eye Itch Relief	Eye Itch Relief
37808-802	Eye Itch Relief	Eye Itch Relief
46122-163	Eye Itch Relief	Eye Itch Relief
49781-075	Eye Itch Relief	Eye Itch Relief
49348-107	eye itch relief	eye itch relief
50804-302	Eye Itch Relief	Eye Itch Relief
59779-705	Eye Itch Relief	Eye Itch Relief
59779-920	Eye Itch Relief	Eye Itch Relief
61715-091	Eye Itch Relief	Eye Itch Relief
62011-0232	eye itch relief	eye itch relief
69842-275	Eye Itch Relief	Eye Itch Relief
70000-0522	Eye Itch Relief	Eye Itch Relief
24208-601	Alaway	Ketotifen Fumarate
24208-600	Alaway Preservative Free	ketotifen fumarate
11822-5533	Eye Itch Releif	Ketotifen Fumarate
0179-8601	Ketotifen Fumarate	Ketotifen Fumarate
0363-9060	Ketotifen Fumarate	Ketotifen Fumarate
0536-1222	Ketotifen Fumarate	Ketotifen Fumarate
0536-1252	Ketotifen Fumarate	Ketotifen Fumarate
17478-717	Ketotifen Fumarate	Ketotifen Fumarate
11716-1163	LEADER EYE ITCH RELIEF DROPS	KETOTIFEN FUMARATE
0065-4011	Zaditor	ketotifen fumarate