FDA.reportPublic FDA data

Amoxicillin

Product NDC
21695-314
11-digit product format
216950314
Labeler code
21695
Product ID
21695-314_0b675f9b-1724-4d56-8e4a-396680de436d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA065271
Marketing category
ANDA
Marketing start
2005-09-11
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
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
21695-314-212019-09-24C16284748780-1934fe258-4d25-48b1-e053-8cdaa90a720aAmoxicillin Capsules, USP
21695-314-302019-09-24C16284748780-1934fe258-4d25-48b1-e053-8cdaa90a720aAmoxicillin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-314-21Amoxicillin21 in 1 BOTTLECAPSULE211
21695-314-30Amoxicillin500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-314-21EA - Each21695-314d17fa94f-c10a-46a0-8b70-b514c4035de012012-07-24
21695-314-30EA - Each21695-3141b16039e-b0a4-4f4b-a66a-2ae3c6aae45812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-314AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 2 package rows20100202_b41ecd6b-4c54-44c8-aa3f-1868faad07c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSNb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308191amoxicillin 500 MG Oral CapsulePSNb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308182amoxicillin 250 MG Oral CapsuleSCDb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308191amoxicillin 500 MG Oral CapsuleSCDb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYb41ecd6b-4c54-44c8-aa3f-1868faad07c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-314-212169503142121 in 1 BOTTLEHistorical
21695-314-3021695031430500 in 1 BOTTLEHistorical