FDA.reportPublic FDA data

Amoxicillin

Product NDC
53002-2091
11-digit product format
530022091
Labeler code
53002
Product ID
53002-2091_40de640c-3898-4fc4-89b2-1988be9151de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA061931
Marketing category
ANDA
Marketing start
1990-09-30
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
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
53002-2091-12025-01-30C16284748780-1f386c64a-12ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A
53002-2091-22025-01-30C16284748780-1f386c64a-12ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A
53002-2091-32025-01-30C16284748780-1f386c64a-12ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A
53002-2091-12023-06-07C16284748780-1f386c64a-12ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A
53002-2091-22023-06-07C16284748780-1f386c64a-12ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A
53002-2091-32023-06-07C16284748780-1f386c64a-12ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A
53002-2091-12023-01-30C16284748780-1f386c64a-12ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A
53002-2091-22023-01-30C16284748780-1f386c64a-12ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A
53002-2091-32023-01-30C16284748780-1f386c64a-12ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2091-1Amoxicillin80 mL in 1 BOTTLEPOWDER, FOR SUSPENSION803
53002-2091-2Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1003
53002-2091-3Amoxicillin150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2091AMOXICILLIN POWDER, FOR SUSPENSION [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20230609_9974b879-9f15-41c6-8fd9-91f63b68e2e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN9974b879-9f15-41c6-8fd9-91f63b68e2e73
239191amoxicillin 50 MG/ML Oral SuspensionSCD9974b879-9f15-41c6-8fd9-91f63b68e2e73
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY9974b879-9f15-41c6-8fd9-91f63b68e2e73
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY9974b879-9f15-41c6-8fd9-91f63b68e2e73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2091-15300220910180 mL in 1 BOTTLE (53002-2091-1) 80 ml2019-01-010000-00-00NoNoCurrent
53002-2091-253002209102100 mL in 1 BOTTLE (53002-2091-2) 100 ml2019-01-010000-00-00NoNoCurrent
53002-2091-353002209103150 mL in 1 BOTTLE (53002-2091-3) 150 ml2019-01-010000-00-00NoNoCurrent