FDA.reportPublic FDA data

Amoxicillin

Product NDC
71205-035
11-digit product format
712050035
Labeler code
71205
Product ID
71205-035_23c32fbb-0d4d-4830-883f-0967c8586247
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065228
Marketing category
ANDA
Marketing start
2005-07-13
Substance
AMOXICILLIN
Active strength
875 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN875 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308194

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-035-14Amoxicillin14 in 1 BOTTLETABLET, FILM COATED145
71205-035-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED205
71205-035-30Amoxicillin30 in 1 BOTTLETABLET, FILM COATED305
71205-035-60Amoxicillin60 in 1 BOTTLETABLET, FILM COATED605
71205-035-90Amoxicillin90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-035AMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 5 package rows20200229_7974a666-6d1d-446b-8ea5-f7145dc66358.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN7974a666-6d1d-446b-8ea5-f7145dc663585
308194amoxicillin 875 MG Oral TabletSCD7974a666-6d1d-446b-8ea5-f7145dc663585
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY7974a666-6d1d-446b-8ea5-f7145dc663585

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-035-147120500351414 TABLET, FILM COATED in 1 BOTTLE (71205-035-14) 2019-09-010000-00-00NoNoCurrent
71205-035-207120500352020 TABLET, FILM COATED in 1 BOTTLE (71205-035-20) 2018-05-010000-00-00NoNoCurrent
71205-035-307120500353030 TABLET, FILM COATED in 1 BOTTLE (71205-035-30) 2018-05-010000-00-00NoNoCurrent
71205-035-607120500356060 TABLET, FILM COATED in 1 BOTTLE (71205-035-60) 2018-05-010000-00-00NoNoCurrent
71205-035-907120500359090 TABLET, FILM COATED in 1 BOTTLE (71205-035-90) 2018-05-010000-00-00NoNoCurrent