NDC 0525-0971

ZELNORM

Tegaserod

ZELNORM is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Alfasigma Usa, Inc.. The primary component is Tegaserod.

• Product ID: 0525-0971_2159f794-0f55-48b5-833c-ff1db7567bed
• NDC: 0525-0971
• Product Type: Human Prescription Drug
• Proprietary Name: ZELNORM
• Generic Name: Tegaserod
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA021200
• Labeler Name: Alfasigma USA, Inc.
• Substance Name: TEGASEROD
• Active Ingredient Strength: 6 mg/1
• Pharm Classes: Serotonin 4 Receptor Antagonists [MoA],Serotonin-4 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0525-0971-10

1 BLISTER PACK in 1 CARTON (0525-0971-10) > 10 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2019-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0525-0971-60 [00525097160]

ZELNORM TABLET

• Marketing Category: NDA
• Application Number: NDA021200
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-08-01

NDC 0525-0971-30 [00525097130]

ZELNORM TABLET

• Marketing Category: NDA
• Application Number: NDA021200
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-08-01

NDC 0525-0971-10 [00525097110]

ZELNORM TABLET

• Marketing Category: NDA
• Application Number: NDA021200
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-08-01

Drug Details

Active Ingredients

Ingredient	Strength
TEGASEROD	6 mg/1

Pharmacological Class

• Serotonin 4 Receptor Antagonists [MoA]
• Serotonin-4 Receptor Antagonist [EPC]
• Serotonin 4 Receptor Antagonists [MoA]
• Serotonin-4 Receptor Antagonist [EPC]

NDC Crossover Matching brand name "ZELNORM" or generic name "Tegaserod"

NDC	Brand Name	Generic Name
0525-0971	ZELNORM	tegaserod
27505-090	Zelnorm	tegaserod