AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC: 71335-2917
11-digit product format: 713352917
Labeler code: 71335
Product ID: 71335-2917_41da82ab-fa80-7eba-e063-6394a90a037e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA204755
Marketing category: ANDA
Marketing start: 2017-03-01
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 875; 125 mg/1; mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-2917_41da82ab-fa80-7eba-e063-6394a90a037e
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: AMOXICILLIN AND CLAVULANATE POTASSIUM
Generic name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2017-03-01
Marketing category: ANDA
Application number: ANDA204755
Pharmacologic classes: Penicillin-class Antibacterial [EPC]; Penicillins [CS]; beta Lactamase Inhibitor [EPC]; beta Lactamase Inhibitors [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
AMOXICILLIN	875 mg/1
CLAVULANATE POTASSIUM	125 mg/1

UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN
Q42OMW3AT8	CLAVULANATE POTASSIUM	61177-45-5	CLAVULANATE POTASSIUM

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2917-1	71335291701	100 TABLET, FILM COATED in 1 BOTTLE (71335-2917-1)	2025-10-23	No	No	Current

Title	Manufacturer	Effective date	Type	Version
AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	2025-10-23	HUMAN PRESCRIPTION DRUG LABEL	100