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Amlodipine besylate - Medication Information

Product NDC Code 65841-621
Drug Name

Amlodipine besylate

Type Generic
Pharm Class Calcium Channel Antagonists [MoA],
Calcium Channel Blocker [EPC],
Cytochrome P450 3A Inhibitors [MoA],
Dihydropyridine Calcium Channel Blocker [EPC],
Dihydropyridines [CS]
Active Ingredients
Amlodipine besylate 5 mg/1
Route ORAL
Dosage Form TABLET
Application Number ANDA078226
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-621-01 100 tablet in 1 bottle (65841-621-01)
65841-621-05 500 tablet in 1 bottle (65841-621-05)
65841-621-16 90 tablet in 1 bottle (65841-621-16)
65841-621-77 10 blister pack in 1 carton (65841-621-77) / 10 tablet in 1 blister pack
Check if available Online

Spl product data elements

Usually a list of ingredients in a drug product.
Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF-WHITE ROUND Z;7 Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF-WHITE ROUND Z;3 Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF-WHITE ROUND Z;5

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-620-16 in bottle of 90 tablets Amlodipine Besylate Tablets USP, 2.5 mg Rx only 90 tablets NDC 65841-621-16 in bottle of 90 tablets Amlodipine Besylate Tablets USP, 5 mg Rx only 90 tablets NDC 65841-622-16 in bottle of 90 tablets Amlodipine Besylate Tablets USP, 10 mg Rx only 90 tablets Amlodipine Besylate Tablets USP, 2.5 mg Amlodipine Besylate Tablets USP, 5 mg Amlodipine Besylate Tablets USP, 10 mg

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API