Amoxicillin

Product NDC
10544-096
11-digit product format
105440096
Labeler code
10544
Product ID
10544-096_9d8e8cc9-6ddc-400f-aeed-b7e2db293f4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA062058
Marketing category
ANDA
Marketing start
2013-01-16
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-096-21Amoxicillin21 in 1 BOTTLECAPSULE211
10544-096-30Amoxicillin30 in 1 BOTTLECAPSULE301
10544-096-42Amoxicillin42 in 1 BOTTLECAPSULE421

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-096AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 3 package rows20130529_3862fdbf-2061-48c3-922f-78276553f7af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN3862fdbf-2061-48c3-922f-78276553f7af1
308191amoxicillin 500 MG Oral CapsuleSCD3862fdbf-2061-48c3-922f-78276553f7af1
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY3862fdbf-2061-48c3-922f-78276553f7af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-096-211054400962121 in 1 BOTTLEHistorical
10544-096-301054400963030 in 1 BOTTLEHistorical
10544-096-421054400964242 in 1 BOTTLEHistorical