70518-3886 NDC - AMOXICILLIN

Drug Information

Product NDC: 70518-3886
Proprietary Name: Amoxicillin
Non Proprietary Name: Amoxicillin
Active Ingredient(s): 500 mg/1 AMOXICILLIN
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Pharmacy Class(es): Penicillin-class Antibacterial [EPC]; Penicillins [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	REMEDYREPACK INC.
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA065256
Marketing Category:	ANDA
Start Marketing Date:	10/5/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	70518-3886-0	100 POUCH in 1 BOX (70518-3886-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3886-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	70518-3886	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Amoxicillin	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Amoxicillin	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	TABLET, FILM COATED	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	10/5/2023	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
MARKETING CATEGORY NAME	ANDA	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
APPLICATION NUMBER	ANDA065256	Name of Company corresponding to the labeler code segment of the Product NDC.
LABELER NAME	REMEDYREPACK INC.	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
SUBSTANCE NAME	AMOXICILLIN
ACTIVE NUMERATOR STRENGTH	500
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Penicillin-class Antibacterial [EPC], Penicillins [CS]

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This page was last updated on: 1/16/2026

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