FDA.reportPublic FDA data

Amoxicillin

Product NDC
55289-182
11-digit product format
552890182
Labeler code
55289
Product ID
55289-182_40d4dda4-d330-a59c-e063-6394a90acc36
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
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-182-06Amoxicillin6 in 1 BOTTLE, PLASTICTABLET, CHEWABLE624
55289-182-09Amoxicillin9 in 1 BOTTLE, PLASTICTABLET, CHEWABLE924
55289-182-14Amoxicillin14 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1424
55289-182-20Amoxicillin20 in 1 BOTTLE, PLASTICTABLET, CHEWABLE2024
55289-182-30Amoxicillin30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE3024
55289-182-40Amoxicillin40 in 1 BOTTLE, PLASTICTABLET, CHEWABLE4024
55289-182-90Amoxicillin90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-182-06EA - Each55289-18273dbf215-c41b-4906-9f27-fa30cebb969712012-07-24
55289-182-09EA - Each55289-18238deb93a-1eb5-41a8-a624-9ba85f359b5e12012-07-24
55289-182-14EA - Each55289-182fd929266-d050-4d42-9987-92a38f1bb2ec12012-07-24
55289-182-20EA - Each55289-1821c56723a-a60f-4232-a9d4-b1b3ec8e161412025-12-16
55289-182-30EA - Each55289-1820e523918-80dc-43bd-8ef5-5162d1fd1ff912012-07-24
55289-182-40EA - Each55289-182a7bc6fe0-bb6e-4bf2-b502-dc1c99f7dd8512012-07-24
55289-182-90EA - Each55289-182d9ad80e7-19c9-4eed-b525-51761870bd5e12016-09-02

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
55289-182AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 7 package rows20250123_98e9274c-c02e-44d9-8cc5-17536ef03a77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598025amoxicillin 250 MG Chewable TabletPSN98e9274c-c02e-44d9-8cc5-17536ef03a7724
598025amoxicillin 250 MG Chewable TabletSCD98e9274c-c02e-44d9-8cc5-17536ef03a7724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-182-06552890182066 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-06) 2015-10-120000-00-00NoNoCurrent
55289-182-09552890182099 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-09) 2015-10-120000-00-00NoNoCurrent
55289-182-145528901821414 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-14) 2015-10-120000-00-00NoNoCurrent
55289-182-205528901822020 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-20) 2025-10-10NoNoCurrent
55289-182-305528901823030 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-30) 2015-10-120000-00-00NoNoCurrent
55289-182-405528901824040 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-40) 2015-10-120000-00-00NoNoCurrent
55289-182-905528901829090 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-90) 2016-08-080000-00-00NoNoCurrent