FDA.reportPublic FDA data

Amoxicillin

Product NDC
70518-3914
11-digit product format
705183914
Labeler code
70518
Product ID
70518-3914_4b05be40-8277-c8e2-e063-6294a90accf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA064076
Marketing category
ANDA
Marketing start
2023-11-13
Substance
AMOXICILLIN
Active strength
500 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
AMOXICILLIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308191

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
70518-3914-0Amoxicillin100 in 1 BOXCAPSULE1008
70518-3914-1Amoxicillin1 in 1 POUCHCAPSULE18
70518-3914-2Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE308
70518-3914-3Amoxicillin21 in 1 BOTTLE, PLASTICCAPSULE218
70518-3914-4Amoxicillin30 in 1 BLISTER PACKCAPSULE308
70518-3914-5Amoxicillin42 in 1 BOTTLE, PLASTICCAPSULE428
70518-3914-6Amoxicillin60 in 1 BOTTLE, PLASTICCAPSULE608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3914AMOXICILLIN CAPSULE [REMEDYREPACK INC.]5Current NDC, 7 package rows20241211_82c0c5d1-df2d-4352-bd12-99f955af569e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN82c0c5d1-df2d-4352-bd12-99f955af569e8
308191amoxicillin 500 MG Oral CapsuleSCD82c0c5d1-df2d-4352-bd12-99f955af569e8
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY82c0c5d1-df2d-4352-bd12-99f955af569e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3914-070518391400100 in 1 BOXHistorical
70518-3914-1705183914011 in 1 POUCHHistorical
70518-3914-27051839140230 in 1 BOTTLE, PLASTICHistorical
70518-3914-37051839140321 in 1 BOTTLE, PLASTICHistorical
70518-3914-47051839140430 CAPSULE in 1 BLISTER PACK (70518-3914-4) 30 capsule2025-06-04NoNoHistorical
70518-3914-57051839140542 CAPSULE in 1 BOTTLE, PLASTIC (70518-3914-5) 42 capsule2026-02-17NoNoHistorical
70518-3914-67051839140660 CAPSULE in 1 BOTTLE, PLASTIC (70518-3914-6) 60 capsule2026-02-17NoNoHistorical