FDA.reportPublic FDA data

Amoxicillin

Product NDC
68071-2364
11-digit product format
680712364
Labeler code
68071
Product ID
68071-2364_4b354727-eaee-119f-e063-6394a90afd77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065322
Marketing category
ANDA
Marketing start
2006-06-19
Substance
AMOXICILLIN
Active strength
250 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui239191

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
68071-2364-82025-01-10C16284748780-1f386c649-d011-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension. AMOXICILLIN for Oral Suspension for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly suspected to be caus
68071-2364-82023-01-30C16284748780-1f386c649-d011-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension. AMOXICILLIN for Oral Suspension for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly suspected to be caus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2364-8Amoxicillin80 mL in 1 BOTTLEPOWDER, FOR SUSPENSION803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2364AMOXICILLIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 1 package rows20250112_bd46de4c-4571-ba9a-e053-2a95a90a792d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSNbd46de4c-4571-ba9a-e053-2a95a90a792d3
239191amoxicillin 50 MG/ML Oral SuspensionSCDbd46de4c-4571-ba9a-e053-2a95a90a792d3
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSYbd46de4c-4571-ba9a-e053-2a95a90a792d3
239191amoxicillin 250 MG per 5 ML Oral SuspensionSYbd46de4c-4571-ba9a-e053-2a95a90a792d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2364-86807123640880 mL in 1 BOTTLE (68071-2364-8) 80 ml2021-03-110000-00-00NoNoCurrent