FDA.reportPublic FDA data

Amoxicillin

Product NDC
12634-185
11-digit product format
126340185
Labeler code
12634
Product ID
12634-185_353028af-ec9d-690b-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA065271
Marketing category
ANDA
Marketing start
2005-11-09
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
12634-185-002021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-012021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-092021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-402021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-502021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-522021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-542021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-572021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-592021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-602021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-612021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-632021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-662021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-672021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-692021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-712021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-742021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-782021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-792021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-802021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-812021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-822021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-852021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-912021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-942021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-952021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
12634-185-962021-01-29C16284748780-1ba0f9c33-3648-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-185-00Amoxicillin10 in 1 BOTTLECAPSULE104
12634-185-01Amoxicillin100 in 1 BOTTLECAPSULE1004
12634-185-09Amoxicillin35 in 1 BOTTLECAPSULE354
12634-185-40Amoxicillin40 in 1 BOTTLECAPSULE404
12634-185-50Amoxicillin50 in 1 BOTTLECAPSULE504
12634-185-52Amoxicillin12 in 1 BLISTER PACKCAPSULE124
12634-185-54Amoxicillin14 in 1 BLISTER PACKCAPSULE144
12634-185-57Amoxicillin20 in 1 BLISTER PACKCAPSULE204
12634-185-59Amoxicillin30 in 1 BLISTER PACKCAPSULE304
12634-185-60Amoxicillin60 in 1 BOTTLECAPSULE604
12634-185-61Amoxicillin10 in 1 BLISTER PACKCAPSULE104
12634-185-63Amoxicillin3 in 1 BLISTER PACKCAPSULE34
12634-185-66Amoxicillin6 in 1 BLISTER PACKCAPSULE64
12634-185-67Amoxicillin7 in 1 BLISTER PACKCAPSULE74
12634-185-69Amoxicillin9 in 1 BLISTER PACKCAPSULE94
12634-185-71Amoxicillin30 in 1 BOTTLECAPSULE304
12634-185-74Amoxicillin24 in 1 BOTTLECAPSULE244
12634-185-78Amoxicillin28 in 1 BOTTLECAPSULE284
12634-185-79Amoxicillin25 in 1 BOTTLECAPSULE254
12634-185-80Amoxicillin20 in 1 BOTTLECAPSULE204
12634-185-81Amoxicillin21 in 1 BOTTLECAPSULE214
12634-185-82Amoxicillin12 in 1 BOTTLECAPSULE124
12634-185-85Amoxicillin15 in 1 BOTTLECAPSULE154
12634-185-91Amoxicillin1 in 1 BLISTER PACKCAPSULE14
12634-185-94Amoxicillin4 in 1 BOTTLECAPSULE44
12634-185-95Amoxicillin5 in 1 BOTTLECAPSULE54
12634-185-96Amoxicillin6 in 1 BOTTLECAPSULE64

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-185AMOXICILLIN CAPSULE [APOTHECA INC.]4Legacy NDC, 27 package rows20160618_f884225c-7845-4df1-ba35-dc53010ed0b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSNf884225c-7845-4df1-ba35-dc53010ed0b04
308191amoxicillin 500 MG Oral CapsulePSNf884225c-7845-4df1-ba35-dc53010ed0b04
308182amoxicillin 250 MG Oral CapsuleSCDf884225c-7845-4df1-ba35-dc53010ed0b04
308191amoxicillin 500 MG Oral CapsuleSCDf884225c-7845-4df1-ba35-dc53010ed0b04
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYf884225c-7845-4df1-ba35-dc53010ed0b04
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYf884225c-7845-4df1-ba35-dc53010ed0b04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-185-001263401850010 in 1 BOTTLEHistorical
12634-185-0112634018501100 in 1 BOTTLEHistorical
12634-185-091263401850935 in 1 BOTTLEHistorical
12634-185-401263401854040 in 1 BOTTLEHistorical
12634-185-501263401855050 in 1 BOTTLEHistorical
12634-185-521263401855212 in 1 BLISTER PACKHistorical
12634-185-541263401855414 in 1 BLISTER PACKHistorical
12634-185-571263401855720 in 1 BLISTER PACKHistorical
12634-185-591263401855930 in 1 BLISTER PACKHistorical
12634-185-601263401856060 in 1 BOTTLEHistorical
12634-185-611263401856110 in 1 BLISTER PACKHistorical
12634-185-63126340185633 in 1 BLISTER PACKHistorical
12634-185-66126340185666 in 1 BLISTER PACKHistorical
12634-185-67126340185677 in 1 BLISTER PACKHistorical
12634-185-69126340185699 in 1 BLISTER PACKHistorical
12634-185-711263401857130 in 1 BOTTLEHistorical
12634-185-741263401857424 in 1 BOTTLEHistorical
12634-185-781263401857828 in 1 BOTTLEHistorical
12634-185-791263401857925 in 1 BOTTLEHistorical
12634-185-801263401858020 in 1 BOTTLEHistorical
12634-185-811263401858121 in 1 BOTTLEHistorical
12634-185-821263401858212 in 1 BOTTLEHistorical
12634-185-851263401858515 in 1 BOTTLEHistorical
12634-185-91126340185911 in 1 BLISTER PACKHistorical
12634-185-94126340185944 in 1 BOTTLEHistorical
12634-185-95126340185955 in 1 BOTTLEHistorical
12634-185-96126340185966 in 1 BOTTLEHistorical