FDA.reportPublic FDA data

Amoxicillin

Product NDC
21695-418
11-digit product format
216950418
Labeler code
21695
Product ID
21695-418_432287dc-6d16-4a64-bc5f-ec1327104f7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA064013
Marketing category
ANDA
Marketing start
2010-01-28
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-418-302019-09-24C16284748780-1934fe258-4d6a-48b1-e053-8cdaa90a720aAMOXICILLIN CAPSULES USP, 250 mg and 500 mg/ AMOXICILLIN FOR ORAL SUSPENSION USP, 125 mg per 5 mL and 250 mg per 5 mL/AMOXICILLIN TABLETS USP (CHEWABLE), 125 mg and 250 mg 3107 3109 2267 2268 4150 4155 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-418-30Amoxicillin30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-418-30EA - Each21695-418eb6933eb-b01d-4338-9101-1ef19b60ed7b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET [REBEL DISTRIBUTORS CORP.]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GAMOXICILLIN TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET [REBEL DISTRIBUTORS CORP.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN TABLET [REBEL DISTRIBUTORS CORP.]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-418AMOXICILLIN TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20101123_432287dc-6d16-4a64-bc5f-ec1327104f7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598025amoxicillin 250 MG Chewable TabletPSN432287dc-6d16-4a64-bc5f-ec1327104f7e1
598025amoxicillin 250 MG Chewable TabletSCD432287dc-6d16-4a64-bc5f-ec1327104f7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-418-302169504183030 in 1 BOTTLEHistorical