AMOXICILLIN

Product NDC
63187-013
11-digit product format
631870013
Labeler code
63187
Product ID
63187-013_7f4ab0f1-5f3f-422a-a945-f4f664ceb12d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA050754
Marketing category
NDA
Marketing start
1978-07-10
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
875 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
63187-013-20EA - Each63187-013c07989db-c2bc-4a29-9dce-a8fcf747464812023-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SODIUMINACTIVE INGREDIENT9NEZ333N27AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-013AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]4Legacy NDC20191121_5d080267-a1ad-4714-8fcd-ca291fbd1ef4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-013-206318700132020 TABLET, FILM COATED in 1 BOTTLE (63187-013-20) 2018-12-010000-00-00NoNoCurrent