Amoxicillin

Product NDC
65862-015
11-digit product format
658620015
Labeler code
65862
Product ID
65862-015_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
875 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
AMOXICILLIN875 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
65862-015-01Amoxicillin100 in 1 BOTTLETABLET, FILM COATED10017
65862-015-05Amoxicillin500 in 1 BOTTLETABLET, FILM COATED50017
65862-015-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED2017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-015-01EA - Each65862-015db23ecaa-6809-4e97-bcfb-9dc3c742b76c12012-07-24
65862-015-05EA - Each65862-0159b386731-410c-4274-8a2a-66c42428d18712012-07-24

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
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-015AMOXICILLIN 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
308194amoxicillin 875 MG Oral TabletPSN9618d038-e880-47f6-b8d7-bbf8ab35364d16
308194amoxicillin 875 MG Oral TabletSCD9618d038-e880-47f6-b8d7-bbf8ab35364d16
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY9618d038-e880-47f6-b8d7-bbf8ab35364d16
308194amoxicillin 875 MG Oral TabletPSN00fbd46e-05fd-4f8a-9f59-a7a4d01c8e5414
308194amoxicillin 875 MG Oral TabletSCD00fbd46e-05fd-4f8a-9f59-a7a4d01c8e5414
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY00fbd46e-05fd-4f8a-9f59-a7a4d01c8e5414
308194amoxicillin 875 MG Oral TabletPSN2700df91-c5ef-4931-9ad7-a3c1c146ccac7
308194amoxicillin 875 MG Oral TabletSCD2700df91-c5ef-4931-9ad7-a3c1c146ccac7
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY2700df91-c5ef-4931-9ad7-a3c1c146ccac7
308194amoxicillin 875 MG Oral TabletPSN586a5911-e30b-40ed-a056-9e67920ca9513
308194amoxicillin 875 MG Oral TabletSCD586a5911-e30b-40ed-a056-9e67920ca9513
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY586a5911-e30b-40ed-a056-9e67920ca9513
308194amoxicillin 875 MG Oral TabletPSN31c12a11-7bce-4457-b413-feaad0da9c492
308194amoxicillin 875 MG Oral TabletPSN271ddc63-b31b-2f46-e054-00144ff8d46c2
308194amoxicillin 875 MG Oral TabletPSN7a15d4c8-d214-446a-8d24-8b2defdf8e022
308194amoxicillin 875 MG Oral TabletPSN5037e2a5-52e9-caec-e063-6294a90ad8372
308194amoxicillin 875 MG Oral TabletSCD5037e2a5-52e9-caec-e063-6294a90ad8372
308194amoxicillin 875 MG Oral TabletSCD7a15d4c8-d214-446a-8d24-8b2defdf8e022
308194amoxicillin 875 MG Oral TabletSCD271ddc63-b31b-2f46-e054-00144ff8d46c2
308194amoxicillin 875 MG Oral TabletSCD31c12a11-7bce-4457-b413-feaad0da9c492
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY31c12a11-7bce-4457-b413-feaad0da9c492
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY5037e2a5-52e9-caec-e063-6294a90ad8372
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY271ddc63-b31b-2f46-e054-00144ff8d46c2
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY7a15d4c8-d214-446a-8d24-8b2defdf8e022
308194amoxicillin 875 MG Oral TabletPSNbc4ce768-a615-4458-9d60-baeada6886cd1
308194amoxicillin 875 MG Oral TabletPSN6b577898-b36a-425c-8cf3-36230347b2d21
308194amoxicillin 875 MG Oral TabletPSN9179bb1b-8554-4c00-a323-aac951ae2f551
308194amoxicillin 875 MG Oral TabletSCD9179bb1b-8554-4c00-a323-aac951ae2f551
308194amoxicillin 875 MG Oral TabletSCDbc4ce768-a615-4458-9d60-baeada6886cd1
308194amoxicillin 875 MG Oral TabletSCD6b577898-b36a-425c-8cf3-36230347b2d21
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYbc4ce768-a615-4458-9d60-baeada6886cd1
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY9179bb1b-8554-4c00-a323-aac951ae2f551
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY6b577898-b36a-425c-8cf3-36230347b2d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-015-0165862001501100 TABLET, FILM COATED in 1 BOTTLE (65862-015-01) 2005-11-090000-00-00NoNoCurrent
65862-015-0565862001505500 TABLET, FILM COATED in 1 BOTTLE (65862-015-05) 2005-11-090000-00-00NoNoCurrent
65862-015-206586200152020 TABLET, FILM COATED in 1 BOTTLE (65862-015-20) 2005-11-090000-00-00NoNoCurrent
65862-015-8965862001589900 TABLET, FILM COATED in 1 BAG (65862-015-89)09-NOV-05Current
65862-015-99658620015991000 TABLET, FILM COATED in 1 BAG (65862-015-99)09-NOV-05Current