FDA.reportPublic FDA data

Amoxicillin

Product NDC
68071-4468
11-digit product format
680714468
Labeler code
68071
Product ID
68071-4468_1a8d6ebc-8df1-3329-e063-6394a90a06e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA064076
Marketing category
ANDA
Marketing start
1994-09-30
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
Rxcui308191

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
68071-4468-12024-06-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-22024-06-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-32024-06-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-42024-06-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-52024-06-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-72024-06-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-82024-06-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-12023-01-30C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-22023-01-30C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-32023-01-30C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-42023-01-30C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-52023-01-30C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-72023-01-30C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-82023-01-30C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-12021-02-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-22021-02-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-32021-02-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-42021-02-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-52021-02-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-72021-02-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-82021-02-10C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-12021-01-29C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-22021-01-29C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-32021-01-29C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-42021-01-29C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-52021-01-29C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-72021-01-29C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974
68071-4468-82021-01-29C16284748780-1ba0f9c33-2506-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4468-1Amoxicillin21 in 1 BOTTLECAPSULE215
68071-4468-2Amoxicillin20 in 1 BOTTLECAPSULE205
68071-4468-3Amoxicillin30 in 1 BOTTLECAPSULE305
68071-4468-4Amoxicillin40 in 1 BOTTLECAPSULE405
68071-4468-5Amoxicillin56 in 1 BOTTLECAPSULE565
68071-4468-7Amoxicillin15 in 1 BOTTLECAPSULE155
68071-4468-8Amoxicillin28 in 1 BOTTLECAPSULE285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4468AMOXICILLIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 7 package rows20240612_6e9bf369-2f96-c7ae-e053-2a91aa0a715f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN6e9bf369-2f96-c7ae-e053-2a91aa0a715f5
308191amoxicillin 500 MG Oral CapsuleSCD6e9bf369-2f96-c7ae-e053-2a91aa0a715f5
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY6e9bf369-2f96-c7ae-e053-2a91aa0a715f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4468-16807144680121 CAPSULE in 1 BOTTLE (68071-4468-1) 21 capsule2018-06-140000-00-00NoNoCurrent
68071-4468-26807144680220 CAPSULE in 1 BOTTLE (68071-4468-2) 20 capsule2018-06-140000-00-00NoNoCurrent
68071-4468-36807144680330 CAPSULE in 1 BOTTLE (68071-4468-3) 30 capsule2018-06-140000-00-00NoNoCurrent
68071-4468-46807144680440 CAPSULE in 1 BOTTLE (68071-4468-4) 40 capsule2018-06-140000-00-00NoNoCurrent
68071-4468-56807144680556 CAPSULE in 1 BOTTLE (68071-4468-5) 56 capsule2018-06-140000-00-00NoNoCurrent
68071-4468-76807144680715 CAPSULE in 1 BOTTLE (68071-4468-7) 15 capsule2018-06-140000-00-00NoNoCurrent
68071-4468-86807144680828 CAPSULE in 1 BOTTLE (68071-4468-8) 28 capsule2018-06-140000-00-00NoNoCurrent