Amoxicillin

Product NDC
70518-3886
11-digit product format
705183886
Labeler code
70518
Product ID
70518-3886_3f8d44fe-be39-c260-e063-6294a90a7c23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065256
Marketing category
ANDA
Marketing start
2023-10-05
Substance
AMOXICILLIN
Active strength
500 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
AMOXICILLIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308192

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
70518-3886-0Amoxicillin100 in 1 BOXTABLET, FILM COATED1006
70518-3886-1Amoxicillin1 in 1 POUCHTABLET, FILM COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3886AMOXICILLIN TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, 2 package rows20250321_f37eb415-77b2-41b0-8d20-64e821e4b05d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308192amoxicillin 500 MG Oral TabletPSNf37eb415-77b2-41b0-8d20-64e821e4b05d6
308192amoxicillin 500 MG Oral TabletSCDf37eb415-77b2-41b0-8d20-64e821e4b05d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3886-070518388600100 POUCH in 1 BOX (70518-3886-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3886-1) 100 pouch2023-10-05NoNoCurrent
70518-3886-1705183886011 in 1 POUCHHistorical