FDA.reportPublic FDA data

Amoxicillin

Product NDC
68071-4548
11-digit product format
680714548
Labeler code
68071
Product ID
68071-4548_1a91478a-32b8-622d-e063-6294a90a7e51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
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
68071-4548-32021-02-19C16284748780-1ba0f9c33-5063-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
68071-4548-42021-02-19C16284748780-1ba0f9c33-5063-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
68071-4548-62021-02-19C16284748780-1ba0f9c33-5063-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
68071-4548-82021-02-19C16284748780-1ba0f9c33-5063-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
68071-4548-32021-01-29C16284748780-1ba0f9c33-5063-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
68071-4548-42021-01-29C16284748780-1ba0f9c33-5063-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
68071-4548-62021-01-29C16284748780-1ba0f9c33-5063-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
68071-4548-82021-01-29C16284748780-1ba0f9c33-5063-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
68071-4548-3Amoxicillin3 in 1 BOTTLECAPSULE36
68071-4548-4Amoxicillin4 in 1 BOTTLECAPSULE46
68071-4548-6Amoxicillin6 in 1 BOTTLECAPSULE66
68071-4548-8Amoxicillin18 in 1 BOTTLECAPSULE186
68071-4548-9Amoxicillin9 in 1 BOTTLECAPSULE96

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4548AMOXICILLIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 5 package rows20240612_7524da98-b0a5-3db8-e053-2a91aa0a6ff1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN7524da98-b0a5-3db8-e053-2a91aa0a6ff16
308191amoxicillin 500 MG Oral CapsuleSCD7524da98-b0a5-3db8-e053-2a91aa0a6ff16
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY7524da98-b0a5-3db8-e053-2a91aa0a6ff16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4548-3680714548033 CAPSULE in 1 BOTTLE (68071-4548-3) 3 capsule2018-09-050000-00-00NoNoCurrent
68071-4548-4680714548044 CAPSULE in 1 BOTTLE (68071-4548-4) 4 capsule2018-09-050000-00-00NoNoCurrent
68071-4548-6680714548066 CAPSULE in 1 BOTTLE (68071-4548-6) 6 capsule2018-09-050000-00-00NoNoCurrent
68071-4548-86807145480818 CAPSULE in 1 BOTTLE (68071-4548-8) 18 capsule2018-09-050000-00-00NoNoCurrent
68071-4548-9680714548099 CAPSULE in 1 BOTTLE (68071-4548-9) 9 capsule2018-09-050000-00-00NoNoCurrent