Amoxicillin

Product NDC
63187-325
11-digit product format
631870325
Labeler code
63187
Product ID
63187-325_ee0246be-6005-448d-a230-42a1ea44fe2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065256
Marketing category
ANDA
Marketing start
2005-11-09
Substance
AMOXICILLIN
Active strength
875 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN875 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308194

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-325-14Amoxicillin14 in 1 BOTTLETABLET, FILM COATED146
63187-325-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-325-14EA - Each63187-32532a72f65-0975-446f-a5d5-e0b470461ebd12018-12-13
63187-325-20EA - Each63187-3250da9f85d-7f7d-4d79-a8d9-5f416a1ea16812024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PAMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-325AMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 2 package rows20220505_313ea909-5b1b-41ff-a0db-5aadc12e2e4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN313ea909-5b1b-41ff-a0db-5aadc12e2e4f6
308194amoxicillin 875 MG Oral TabletSCD313ea909-5b1b-41ff-a0db-5aadc12e2e4f6
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY313ea909-5b1b-41ff-a0db-5aadc12e2e4f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-325-146318703251414 TABLET, FILM COATED in 1 BOTTLE (63187-325-14) 2018-10-010000-00-00NoNoCurrent
63187-325-206318703252020 TABLET, FILM COATED in 1 BOTTLE (63187-325-20) 2015-06-010000-00-00NoNoCurrent