FDA.reportPublic FDA data

Amoxicillin

Product NDC
70518-2191
11-digit product format
705182191
Labeler code
70518
Product ID
70518-2191_49dbf57d-96d4-d3d6-e063-6394a90ac2d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065256
Marketing category
ANDA
Marketing start
2019-07-09
Substance
AMOXICILLIN
Active strength
875 mg/1
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
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2191-0Amoxicillin20 in 1 BLISTER PACKTABLET, FILM COATED2016
70518-2191-1Amoxicillin30 in 1 BLISTER PACKTABLET, FILM COATED3016
70518-2191-2Amoxicillin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2016
70518-2191-3Amoxicillin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1416
70518-2191-4Amoxicillin14 in 1 BLISTER PACKTABLET, FILM COATED1416

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2191AMOXICILLIN TABLET, FILM COATED [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 5 package rows20250309_9618d038-e880-47f6-b8d7-bbf8ab35364d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN9618d038-e880-47f6-b8d7-bbf8ab35364d16
308194amoxicillin 875 MG Oral TabletSCD9618d038-e880-47f6-b8d7-bbf8ab35364d16
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY9618d038-e880-47f6-b8d7-bbf8ab35364d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2191-07051821910020 TABLET, FILM COATED in 1 BLISTER PACK (70518-2191-0) 2019-07-090000-00-00NoNoCurrent
70518-2191-17051821910130 TABLET, FILM COATED in 1 BLISTER PACK (70518-2191-1) 2019-07-090000-00-00NoNoCurrent
70518-2191-27051821910220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2191-2) 2019-07-190000-00-00NoNoCurrent
70518-2191-37051821910314 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2191-3) 2019-07-190000-00-00NoNoCurrent
70518-2191-47051821910414 TABLET, FILM COATED in 1 BLISTER PACK (70518-2191-4) 2020-07-080000-00-00NoNoCurrent