FDA.reportPublic FDA data

Amoxicillin

Product NDC
65862-014
11-digit product format
658620014
Labeler code
65862
Product ID
65862-014_ee0e12cd-e881-4048-a0fb-74bd771cb9aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308192, 308194

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-014-01Amoxicillin100 in 1 BOTTLETABLET, FILM COATED10017
65862-014-05Amoxicillin500 in 1 BOTTLETABLET, FILM COATED50017
65862-014-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED2017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-014-01EA - Each65862-0147a548b75-426a-4a0f-817a-f5ae10a1660612012-07-24
65862-014-05EA - Each65862-0140ba35d39-8be5-4aca-ae9b-9063ec35054d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-014AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]17Current NDC, Legacy NDC, 3 package rows20240613_99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308192amoxicillin 500 MG Oral TabletPSNc3d3f94f-e976-4625-9667-3d716932f2fa29
308194amoxicillin 875 MG Oral TabletPSNc3d3f94f-e976-4625-9667-3d716932f2fa29
308192amoxicillin 500 MG Oral TabletSCDc3d3f94f-e976-4625-9667-3d716932f2fa29
308194amoxicillin 875 MG Oral TabletSCDc3d3f94f-e976-4625-9667-3d716932f2fa29
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYc3d3f94f-e976-4625-9667-3d716932f2fa29
308192amoxicillin 500 MG Oral TabletPSN99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e17
308194amoxicillin 875 MG Oral TabletPSN99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e17
308192amoxicillin 500 MG Oral TabletSCD99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e17
308194amoxicillin 875 MG Oral TabletSCD99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e17
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e17
308192amoxicillin 500 MG Oral TabletPSNaf3d94aa-e982-4d89-95e0-164a521f7cbe2
308192amoxicillin 500 MG Oral TabletSCDaf3d94aa-e982-4d89-95e0-164a521f7cbe2
308192amoxicillin 500 MG Oral TabletPSN3880b9c2-62a5-0d23-e063-6394a90a12521
308192amoxicillin 500 MG Oral TabletPSN3e4f0f03-438b-ddfb-e063-6294a90adb381
308192amoxicillin 500 MG Oral TabletSCD3880b9c2-62a5-0d23-e063-6394a90a12521
308192amoxicillin 500 MG Oral TabletSCD3e4f0f03-438b-ddfb-e063-6294a90adb381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-014-0165862001401100 TABLET, FILM COATED in 1 BOTTLE (65862-014-01) 2005-11-090000-00-00NoNoCurrent
65862-014-0565862001405500 TABLET, FILM COATED in 1 BOTTLE (65862-014-05) 2005-11-090000-00-00NoNoCurrent
65862-014-206586200142020 TABLET, FILM COATED in 1 BOTTLE (65862-014-20) 2005-11-090000-00-00NoNoCurrent
65862-014-22658620014222000 TABLET, FILM COATED in 1 BAG (65862-014-22)09-NOV-05Current
65862-014-31658620014311700 TABLET, FILM COATED in 1 BAG (65862-014-31)09-NOV-05Current