FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-1795
11-digit product format
500901795
Labeler code
50090
Product ID
50090-1795_4e10c059-531c-4eeb-9b8c-a597f3756c4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065271
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
Rxcui308182, 308191

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
50090-1795-42023-02-06C16284748780-1f386c64a-297e-0266-e053-dadaa90a7c1aThese 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
50090-1795-52023-02-06C16284748780-1f386c64a-297e-0266-e053-dadaa90a7c1aThese 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
50090-1795-62023-02-06C16284748780-1f386c64a-297e-0266-e053-dadaa90a7c1aThese 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
50090-1795-72023-02-06C16284748780-1f386c64a-297e-0266-e053-dadaa90a7c1aThese 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
50090-1795-42023-01-30C16284748780-1f386c64a-297e-0266-e053-dadaa90a7c1aThese 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
50090-1795-52023-01-30C16284748780-1f386c64a-297e-0266-e053-dadaa90a7c1aThese 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
50090-1795-62023-01-30C16284748780-1f386c64a-297e-0266-e053-dadaa90a7c1aThese 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
50090-1795-72023-01-30C16284748780-1f386c64a-297e-0266-e053-dadaa90a7c1aThese 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
50090-1795-4Amoxicillin56 in 1 BOTTLECAPSULE5617
50090-1795-5Amoxicillin4 in 1 BOTTLECAPSULE417
50090-1795-6Amoxicillin20 in 1 BOTTLECAPSULE2017
50090-1795-7Amoxicillin100 in 1 BOTTLECAPSULE10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1795-4EA - Each50090-17951a36b8b9-3a41-40bc-8770-cb7f8aaef82412024-12-10
50090-1795-5EA - Each50090-1795bfaf9c25-5b9d-4b85-b2b2-1e9f27bff01212024-12-10
50090-1795-6EA - Each50090-1795bc48bf9b-9def-44b6-9f25-b23741222d5712021-09-07
50090-1795-7EA - Each50090-17958a51993a-f043-435c-b7fd-a89bf25c292a12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1795AMOXICILLIN CAPSULE [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 4 package rows20241105_5edc5d32-43d5-4418-9832-40363a919edc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN5edc5d32-43d5-4418-9832-40363a919edc17
308191amoxicillin 500 MG Oral CapsulePSN5edc5d32-43d5-4418-9832-40363a919edc17
308182amoxicillin 250 MG Oral CapsuleSCD5edc5d32-43d5-4418-9832-40363a919edc17
308191amoxicillin 500 MG Oral CapsuleSCD5edc5d32-43d5-4418-9832-40363a919edc17
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY5edc5d32-43d5-4418-9832-40363a919edc17
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY5edc5d32-43d5-4418-9832-40363a919edc17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1795-45009017950456 CAPSULE in 1 BOTTLE (50090-1795-4) 56 capsule2015-04-29NoNoHistorical
50090-1795-5500901795054 CAPSULE in 1 BOTTLE (50090-1795-5) 4 capsule2015-04-29NoNoHistorical
50090-1795-65009017950620 CAPSULE in 1 BOTTLE (50090-1795-6) 20 capsule2015-04-290000-00-00NoNoCurrent
50090-1795-750090179507100 CAPSULE in 1 BOTTLE (50090-1795-7) 100 capsule2015-04-29NoNoHistorical