FDA.reportPublic FDA data

Amoxicillin

Product NDC
53002-2090
11-digit product format
530022090
Labeler code
53002
Product ID
53002-2090_1bec764a-9031-406d-9840-745732975b38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065387
Marketing category
ANDA
Marketing start
2007-03-26
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/5mL
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-2090-12025-01-30C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-22025-01-30C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-32025-01-30C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-12023-06-08C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-22023-06-08C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-32023-06-08C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-12023-01-30C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-22023-01-30C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-32023-01-30C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-12020-12-15C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-22020-12-15C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-32020-12-15C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-12020-01-31C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-22020-01-31C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-32020-01-31C16284748780-19d75b9d0-6481-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2090-1Amoxicillin80 mL in 1 BOTTLEPOWDER, FOR SUSPENSION808
53002-2090-2Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1008
53002-2090-3Amoxicillin150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2090AMOXICILLIN POWDER, FOR SUSPENSION [RPK PHARMACEUTICALS, INC.]8Legacy NDC, 3 package rows20230609_196b4f19-c965-4c88-ab15-3705c2ccef74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN196b4f19-c965-4c88-ab15-3705c2ccef748
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN196b4f19-c965-4c88-ab15-3705c2ccef748
239191amoxicillin 50 MG/ML Oral SuspensionSCD196b4f19-c965-4c88-ab15-3705c2ccef748
308189amoxicillin 80 MG/ML Oral SuspensionSCD196b4f19-c965-4c88-ab15-3705c2ccef748
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY196b4f19-c965-4c88-ab15-3705c2ccef748
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY196b4f19-c965-4c88-ab15-3705c2ccef748
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY196b4f19-c965-4c88-ab15-3705c2ccef748

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2090-15300220900180 mL in 1 BOTTLE (53002-2090-1) 80 ml2018-10-010000-00-00NoNoCurrent
53002-2090-253002209002100 mL in 1 BOTTLE (53002-2090-2) 100 ml2018-10-010000-00-00NoNoCurrent
53002-2090-353002209003150 mL in 1 BOTTLE (53002-2090-3) 150 ml2018-10-010000-00-00NoNoCurrent