FDA.reportPublic FDA data

Amoxicillin

Product NDC
70934-087
11-digit product format
709340087
Labeler code
70934
Product ID
70934-087_d202d019-b219-6d86-e053-2a95a90a0dc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA064076
Marketing category
ANDA
Marketing start
2019-12-17
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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
70934-087-212023-01-30C16284748780-1ba0f9c33-49f5-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 administration Initial U.S. Approval: 1974
70934-087-302023-01-30C16284748780-1ba0f9c33-49f5-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 administration Initial U.S. Approval: 1974
70934-087-302021-12-29C16284748780-1ba0f9c33-49f5-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 administration Initial U.S. Approval: 1974
70934-087-302021-01-29C16284748780-1ba0f9c33-49f5-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 administration Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-087-21Amoxicillin21 in 1 BOTTLE, PLASTICCAPSULE213
70934-087-30Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-087-30EA - Each70934-087f50fef30-e4fa-49ce-a14e-2b569fa8082212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-087AMOXICILLIN CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 2 package rows20211230_737df78d-f8b3-260e-e053-2a91aa0a4d35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN737df78d-f8b3-260e-e053-2a91aa0a4d353
308182amoxicillin 250 MG Oral CapsuleSCD737df78d-f8b3-260e-e053-2a91aa0a4d353
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY737df78d-f8b3-260e-e053-2a91aa0a4d353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-087-217093400872121 CAPSULE in 1 BOTTLE, PLASTIC (70934-087-21) 21 capsule2019-12-170000-00-00NoNoCurrent
70934-087-307093400873030 CAPSULE in 1 BOTTLE, PLASTIC (70934-087-30) 30 capsule2019-12-170000-00-00NoNoCurrent