Amoxicillin

Product NDC: 72189-463
11-digit product format: 721890463
Labeler code: 72189
Product ID: 72189-463_2c4de9c8-898d-f59d-e063-6294a90afdc1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA065228
Marketing category: ANDA
Marketing start: 2023-04-17
Substance: AMOXICILLIN
Active strength: 875 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 72189-463_2c4de9c8-898d-f59d-e063-6294a90afdc1
SPL ID: 2c4de9c8-898d-f59d-e063-6294a90afdc1
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Amoxicillin
Generic name: Amoxicillin
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2023-04-17
Marketing category: ANDA
Application number: ANDA065228
Pharmacologic classes: Penicillin-class Antibacterial [EPC]; Penicillins [CS]
Listing expiration: 2026-12-31

Ingredient	Strength
AMOXICILLIN	875 mg/1

Package NDC	Description	Marketing start	Sample
72189-463-20	20 TABLET, FILM COATED in 1 BOTTLE (72189-463-20)	2023-04-17	No

UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-463-20	72189046320	20 TABLET, FILM COATED in 1 BOTTLE (72189-463-20)	2023-04-17	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Amoxicillin	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2