FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
82804-969
11-digit product format
828040969
Labeler code
82804
Product ID
82804-969_6313edc5-d2d5-44a1-a06f-7f7829c870d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078414
Marketing category
ANDA
Marketing start
2021-10-01
Substance
AMLODIPINE BESYLATE
Active strength
2.5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMLODIPINE BESYLATE
Brand name suffix
2.5 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui197361, 308135, 308136

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-969-0082804096900100 TABLET in 1 BOTTLE (82804-969-00) 100 tablet2025-02-13NoNoHistorical
82804-969-11828040969111000 TABLET in 1 BOTTLE (82804-969-11) 1000 tablet2025-02-13NoNoHistorical
82804-969-308280409693030 TABLET in 1 BOTTLE (82804-969-30) 30 tablet2025-02-13NoNoHistorical
82804-969-5582804096955500 TABLET in 1 BOTTLE (82804-969-55) 500 tablet2025-02-13NoNoHistorical
82804-969-608280409696060 TABLET in 1 BOTTLE (82804-969-60) 60 tablet2025-02-13NoNoHistorical
82804-969-7282804096972120 TABLET in 1 BOTTLE (82804-969-72) 120 tablet2025-02-13NoNoHistorical
82804-969-908280409699090 TABLET in 1 BOTTLE (82804-969-90) 90 tablet2025-02-13NoNoHistorical