Amoxicillin

Product NDC
50436-0031
11-digit product format
504360031
Labeler code
50436
Product ID
50436-0031_4c6e2c55-6d69-4b6b-aa26-f73411218dfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
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
2023-12-31
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
50436-0031-12024-01-30C16284748780-1ba0f9c33-2fe2-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
50436-0031-22024-01-30C16284748780-1ba0f9c33-2fe2-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
50436-0031-42024-01-30C16284748780-1ba0f9c33-2fe2-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
50436-0031-12022-05-23C16284748780-1ba0f9c33-2fe2-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
50436-0031-42022-05-23C16284748780-1ba0f9c33-2fe2-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
50436-0031-12021-01-29C16284748780-1ba0f9c33-2fe2-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
50436-0031-42021-01-29C16284748780-1ba0f9c33-2fe2-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
50436-0031-1Amoxicillin30 in 1 BOTTLECAPSULE3010
50436-0031-2Amoxicillin30 in 1 BOTTLECAPSULE3010
50436-0031-4Amoxicillin21 in 1 BOTTLECAPSULE2110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0031-1EA - Each50436-0031886b128d-6028-4748-b2aa-28e9096f71ab12017-09-11
50436-0031-4EA - Each50436-003152d633bd-1147-48f2-875f-46cf592b298512017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0031AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]10Legacy NDC, 3 package rows20220524_c9300368-330a-41bd-97ca-c90ea9159c6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSNc9300368-330a-41bd-97ca-c90ea9159c6d10
308191amoxicillin 500 MG Oral CapsuleSCDc9300368-330a-41bd-97ca-c90ea9159c6d10
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYc9300368-330a-41bd-97ca-c90ea9159c6d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-0031-15043600310130 CAPSULE in 1 BOTTLE (50436-0031-1) 30 capsule2016-09-010000-00-00NoNoCurrent
50436-0031-25043600310230 CAPSULE in 1 BOTTLE (50436-0031-2) 30 capsule2022-03-010000-00-00NoNoCurrent
50436-0031-45043600310421 CAPSULE in 1 BOTTLE (50436-0031-4) 21 capsule2016-09-010000-00-00NoNoCurrent