FDA.reportPublic FDA data

Amoxicillin

Product NDC
68071-2911
11-digit product format
680712911
Labeler code
68071
Product ID
68071-2911_4b2134dc-4c34-0cfb-e063-6294a90acd23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065256
Marketing category
ANDA
Marketing start
2005-11-09
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308192

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2911-12025-01-30C16284748780-12cef2736-7893-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2911-1Amoxicillin100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2911AMOXICILLIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 1 package rows20230111_f1eee459-9021-b26e-e053-2995a90a7291.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308192amoxicillin 500 MG Oral TabletPSNf1eee459-9021-b26e-e053-2995a90a72912
308192amoxicillin 500 MG Oral TabletSCDf1eee459-9021-b26e-e053-2995a90a72912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2911-168071291101100 TABLET, FILM COATED in 1 BOTTLE (68071-2911-1) 2023-01-100000-00-00NoNoCurrent