FDA.reportPublic FDA data

Amoxicillin

Product NDC
43063-341
11-digit product format
430630341
Labeler code
43063
Product ID
43063-341_3a24c129-074d-c363-e063-6394a90a3a3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA064013
Marketing category
ANDA
Marketing start
1993-01-01
Substance
AMOXICILLIN
Active strength
250 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
AMOXICILLIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui598025

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-341-04Amoxicillin4 in 1 BOTTLE, PLASTICTABLET, CHEWABLE428

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-341-04EA - Each43063-3412d597785-f31c-4ea2-a443-b7488ce8e48b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]5
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GAMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]5
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-341AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]27Current NDC, Legacy NDC, 1 package rows20240922_09660a95-a7b3-4d1f-832c-a4fa7a5b7ddd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598025amoxicillin 250 MG Chewable TabletPSN09660a95-a7b3-4d1f-832c-a4fa7a5b7ddd28
598025amoxicillin 250 MG Chewable TabletSCD09660a95-a7b3-4d1f-832c-a4fa7a5b7ddd28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-341-04430630341044 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-341-04) 2011-11-260000-00-00NoNoCurrent