Amoxicillin

Product NDC
63187-044
11-digit product format
631870044
Labeler code
63187
Product ID
63187-044_46acdbce-70d1-462a-b60c-cd242b654e3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA062058
Marketing category
ANDA
Marketing start
2012-01-12
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
500 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-044-30EA - Each63187-04419323e57-dc5e-44b4-a6f5-ca4f0f4ad4a712016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [PROFICIENT RX LP]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [PROFICIENT RX LP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE [PROFICIENT RX LP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMOXICILLIN CAPSULE [PROFICIENT RX LP]2
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [PROFICIENT RX LP]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-044AMOXICILLIN CAPSULE [PROFICIENT RX LP]4Legacy NDC20191121_70231a3f-e266-488f-bdfa-d88e3da3464f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-044-216318700442121 CAPSULE in 1 BOTTLE (63187-044-21) 21 capsule2018-11-010000-00-00NoNoCurrent
63187-044-306318700443030 CAPSULE in 1 BOTTLE (63187-044-30) 30 capsule2018-11-010000-00-00NoNoCurrent
63187-044-406318700444040 CAPSULE in 1 BOTTLE (63187-044-40) 40 capsule2018-11-010000-00-00NoNoCurrent