FDA.reportPublic FDA data

Amoxicillin

Product NDC
42708-112
11-digit product format
427080112
Labeler code
42708
Product ID
42708-112_4682c86c-a853-ade0-e063-6394a90acbce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA065056
Marketing category
ANDA
Marketing start
2000-09-26
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42708-112-202021-03-15C16284748780-1ba0f9c33-5c52-a910-e053-dadaa90a0b85These 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
42708-112-202021-01-29C16284748780-1ba0f9c33-5c52-a910-e053-dadaa90a0b85These 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
42708-112-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED2031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-112AMOXICILLIN TABLET, FILM COATED [QPHARMA, INC.]30Current NDC, Legacy NDC, 1 package rows20250523_7f40b439-d826-4a19-b184-702e9bd5a883.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN7f40b439-d826-4a19-b184-702e9bd5a88331
308194amoxicillin 875 MG Oral TabletSCD7f40b439-d826-4a19-b184-702e9bd5a88331
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY7f40b439-d826-4a19-b184-702e9bd5a88331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-112-204270801122020 TABLET, FILM COATED in 1 BOTTLE (42708-112-20) 2018-04-170000-00-00YesNoCurrent