FDA.reportPublic FDA data

Amoxicillin

Product NDC
70934-310
11-digit product format
709340310
Labeler code
70934
Product ID
70934-310_b7b41856-527b-97b1-e053-2a95a90a2671
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA065291
Marketing category
ANDA
Marketing start
2019-03-26
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
2021-12-31
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
70934-310-212023-01-30C16284748780-1f386c649-9967-0266-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 250 mg and 500 mg Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-310-21Amoxicillin21 in 1 BOTTLE, PLASTICCAPSULE212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-310AMOXICILLIN CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 1 package rows20201231_8b256346-944f-54b5-e053-2995a90ae259.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN8b256346-944f-54b5-e053-2995a90ae2592
308191amoxicillin 500 MG Oral CapsuleSCD8b256346-944f-54b5-e053-2995a90ae2592
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY8b256346-944f-54b5-e053-2995a90ae2592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-310-217093403102121 CAPSULE in 1 BOTTLE, PLASTIC (70934-310-21) 21 capsule2019-03-260000-00-00NoNoCurrent