Amoxicillin

Product NDC
63187-043
11-digit product format
631870043
Labeler code
63187
Product ID
63187-043_37ca9099-4aa7-4e1d-b914-40351c7b155b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA062884
Marketing category
ANDA
Marketing start
1988-02-25
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [PROFICIENT RX LP]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [PROFICIENT RX LP]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LAMOXICILLIN CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMOXICILLIN CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-043AMOXICILLIN CAPSULE [PROFICIENT RX LP]3Legacy NDC20191121_61bd8983-9890-463c-be87-aa42af9778c9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-043-306318700433030 CAPSULE in 1 BOTTLE (63187-043-30) 30 capsule2018-11-010000-00-00NoNoCurrent