FDA.reportPublic FDA data

Amoxicillin

Product NDC
70934-033
11-digit product format
709340033
Labeler code
70934
Product ID
70934-033_d203404e-40e5-a15c-e053-2a95a90a9ba1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA065271
Marketing category
ANDA
Marketing start
2017-07-24
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
70934-033-202023-01-30C16284748780-1f386c64a-2c99-0266-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, for oral use Initial U.S. Approval: 1974
70934-033-212023-01-30C16284748780-1f386c64a-2c99-0266-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, for oral use Initial U.S. Approval: 1974
70934-033-302023-01-30C16284748780-1f386c64a-2c99-0266-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, for oral use Initial U.S. Approval: 1974
70934-033-922023-01-30C16284748780-1f386c64a-2c99-0266-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, for oral use Initial U.S. Approval: 1974
70934-033-932023-01-30C16284748780-1f386c64a-2c99-0266-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, for oral use Initial U.S. Approval: 1974
70934-033-942023-01-30C16284748780-1f386c64a-2c99-0266-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, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-033-20Amoxicillin20 in 1 BOTTLE, PLASTICCAPSULE204
70934-033-21Amoxicillin21 in 1 BOTTLE, PLASTICCAPSULE214
70934-033-30Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE304
70934-033-92Amoxicillin21 in 1 DOSE PACKCAPSULE214
70934-033-93Amoxicillin28 in 1 DOSE PACKCAPSULE284
70934-033-94Amoxicillin30 in 1 DOSE PACKCAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-033-20EA - Each70934-0334769a159-c5da-4828-ae66-580ea8101c7b12018-01-12
70934-033-21EA - Each70934-033ecc37a14-d5a9-4126-afb0-9d71e6dd093b12018-01-12
70934-033-30EA - Each70934-03368d7e921-191e-4873-a5a1-71ecb31dfbc012018-01-12
70934-033-92EA - Each70934-03325eb2af1-bdd6-4cf9-b794-2ed98aa3c1c812018-01-12
70934-033-93EA - Each70934-033d2a2c1e4-4a49-45b6-b16e-916a1a5090d912018-01-12
70934-033-94EA - Each70934-0331f25325e-37dd-41a0-880a-f3e168cfd67b12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-033AMOXICILLIN CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]4Legacy NDC, 6 package rows20211230_ed4f3684-602c-4c06-86b9-6ba37499d0b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSNed4f3684-602c-4c06-86b9-6ba37499d0b94
308191amoxicillin 500 MG Oral CapsuleSCDed4f3684-602c-4c06-86b9-6ba37499d0b94
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYed4f3684-602c-4c06-86b9-6ba37499d0b94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-033-207093400332020 CAPSULE in 1 BOTTLE, PLASTIC (70934-033-20) 20 capsule2017-08-010000-00-00NoNoCurrent
70934-033-217093400332121 CAPSULE in 1 BOTTLE, PLASTIC (70934-033-21) 21 capsule2017-06-290000-00-00NoNoCurrent
70934-033-307093400333030 CAPSULE in 1 BOTTLE, PLASTIC (70934-033-30) 30 capsule2017-08-010000-00-00NoNoCurrent
70934-033-927093400339221 CAPSULE in 1 DOSE PACK (70934-033-92) 21 capsule2017-10-230000-00-00NoNoCurrent
70934-033-937093400339328 CAPSULE in 1 DOSE PACK (70934-033-93) 28 capsule2017-10-230000-00-00NoNoCurrent
70934-033-947093400339430 CAPSULE in 1 DOSE PACK (70934-033-94) 30 capsule2017-10-230000-00-00NoNoCurrent