FDA.reportPublic FDA data

Amoxicillin

Product NDC
70934-054
11-digit product format
709340054
Labeler code
70934
Product ID
70934-054_d202d019-b21d-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
2017-12-20
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
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
70934-054-142023-01-30C16284748780-1f386c649-ab39-0266-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 Initial U.S. Approval: 1974
70934-054-202023-01-30C16284748780-1f386c649-ab39-0266-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 Initial U.S. Approval: 1974
70934-054-212023-01-30C16284748780-1f386c649-ab39-0266-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 Initial U.S. Approval: 1974
70934-054-302023-01-30C16284748780-1f386c649-ab39-0266-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 Initial U.S. Approval: 1974
70934-054-402023-01-30C16284748780-1f386c649-ab39-0266-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 Initial U.S. Approval: 1974
70934-054-922023-01-30C16284748780-1f386c649-ab39-0266-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 Initial U.S. Approval: 1974
70934-054-932023-01-30C16284748780-1f386c649-ab39-0266-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 Initial U.S. Approval: 1974
70934-054-942023-01-30C16284748780-1f386c649-ab39-0266-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 Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-054-14Amoxicillin14 in 1 BOTTLE, PLASTICCAPSULE149
70934-054-20Amoxicillin20 in 1 BOTTLE, PLASTICCAPSULE209
70934-054-21Amoxicillin21 in 1 BOTTLE, PLASTICCAPSULE219
70934-054-30Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE309
70934-054-40Amoxicillin40 in 1 BOTTLE, PLASTICCAPSULE409
70934-054-92Amoxicillin21 in 1 DOSE PACKCAPSULE219
70934-054-93Amoxicillin28 in 1 DOSE PACKCAPSULE289
70934-054-94Amoxicillin30 in 1 DOSE PACKCAPSULE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-054-20EA - Each70934-054d8d5e806-dcdd-4dc6-ba72-7ad5c58e257712018-02-20
70934-054-21EA - Each70934-05414960dbe-dc02-48d2-876f-de3e3de21ce912018-02-20
70934-054-30EA - Each70934-05442a93233-51cb-4221-9399-abf042eb2fca12018-02-20
70934-054-40EA - Each70934-054bf7da7f8-ea16-4ff9-b667-8e646211ab4012018-02-20
70934-054-93EA - Each70934-0549fb0f6b7-353d-4216-8f93-7732a12b0ccf12018-11-06
70934-054-94EA - Each70934-0546b3cc665-84a5-4bb3-b7d1-14c660d8577312018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-054AMOXICILLIN CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]9Legacy NDC, 8 package rows20211230_61ceb6f4-3edf-4675-e053-2991aa0a086e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN61ceb6f4-3edf-4675-e053-2991aa0a086e9
308191amoxicillin 500 MG Oral CapsuleSCD61ceb6f4-3edf-4675-e053-2991aa0a086e9
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY61ceb6f4-3edf-4675-e053-2991aa0a086e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-054-147093400541414 CAPSULE in 1 BOTTLE, PLASTIC (70934-054-14) 14 capsule2020-06-160000-00-00NoNoCurrent
70934-054-207093400542020 CAPSULE in 1 BOTTLE, PLASTIC (70934-054-20) 20 capsule2018-01-030000-00-00NoNoCurrent
70934-054-217093400542121 CAPSULE in 1 BOTTLE, PLASTIC (70934-054-21) 21 capsule2017-12-200000-00-00NoNoCurrent
70934-054-307093400543030 CAPSULE in 1 BOTTLE, PLASTIC (70934-054-30) 30 capsule2017-12-200000-00-00NoNoCurrent
70934-054-407093400544040 CAPSULE in 1 BOTTLE, PLASTIC (70934-054-40) 40 capsule2017-12-200000-00-00NoNoCurrent
70934-054-927093400549221 CAPSULE in 1 DOSE PACK (70934-054-92) 21 capsule2018-01-180000-00-00NoNoCurrent
70934-054-937093400549328 CAPSULE in 1 DOSE PACK (70934-054-93) 28 capsule2018-07-100000-00-00NoNoCurrent
70934-054-947093400549430 CAPSULE in 1 DOSE PACK (70934-054-94) 30 capsule2018-01-180000-00-00NoNoCurrent