FDA.reportPublic FDA data

Amoxicillin

Product NDC
10544-619
11-digit product format
105440619
Labeler code
10544
Product ID
10544-619_aeab7666-d9ce-47bd-92b2-b71112076fb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA065291
Marketing category
ANDA
Marketing start
2010-05-17
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
500 mg/1
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-619-212019-10-29C16284748780-1960f7f55-cdee-8e05-e053-dbdaa90a074aAmoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg
10544-619-302019-10-29C16284748780-1960f7f55-cdee-8e05-e053-dbdaa90a074aAmoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg
10544-619-422019-10-29C16284748780-1960f7f55-cdee-8e05-e053-dbdaa90a074aAmoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-619-21Amoxicillin21 in 1 BOTTLECAPSULE212
10544-619-30Amoxicillin30 in 1 BOTTLECAPSULE302
10544-619-42Amoxicillin42 in 1 BOTTLECAPSULE422

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-619-21EA - Each10544-61905f69281-c0fa-4f9a-96b9-c4910b6cd81f12015-02-02
10544-619-30EA - Each10544-61992f04f63-0bd4-4422-91f4-8d37b50fa96412015-02-02
10544-619-42EA - Each10544-6198f44ea29-c930-423c-9ced-95a5cda09a3512015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-619AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 3 package rows20101019_3afc3097-a757-49a0-aaec-85ac267aabb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN3afc3097-a757-49a0-aaec-85ac267aabb12
308191amoxicillin 500 MG Oral CapsuleSCD3afc3097-a757-49a0-aaec-85ac267aabb12
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY3afc3097-a757-49a0-aaec-85ac267aabb12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-619-211054406192121 in 1 BOTTLEHistorical
10544-619-301054406193030 in 1 BOTTLEHistorical
10544-619-421054406194242 in 1 BOTTLEHistorical