Amlodipine Besylate

Product NDC
63187-508
11-digit product format
631870508
Labeler code
63187
Product ID
63187-508_40149712-4747-4aec-8c7d-3033321c4ebe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203245
Marketing category
ANDA
Marketing start
2014-03-03
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-508AMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]5Legacy NDC20200219_f0fdfde7-fd9a-4a6b-bd86-0a14f791c481.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-508-306318705083030 TABLET in 1 BOTTLE, PLASTIC (63187-508-30) 30 tablet2015-02-020000-00-00NoNoCurrent
63187-508-606318705086060 TABLET in 1 BOTTLE, PLASTIC (63187-508-60) 60 tablet2015-02-020000-00-00NoNoCurrent
63187-508-906318705089090 TABLET in 1 BOTTLE, PLASTIC (63187-508-90) 90 tablet2015-02-020000-00-00NoNoCurrent