CIPROFLOXACIN

Product NDC: 72189-323
11-digit product format: 721890323
Labeler code: 72189
Product ID: 72189-323_2c3d4146-03d9-30a9-e063-6294a90ad471
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CIPROFLOXACIN
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Direct Rx
Application: ANDA208921
Marketing category: ANDA
Marketing start: 2022-02-21
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 250 mg/1
Pharmacologic classes: Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 72189-323_2c3d4146-03d9-30a9-e063-6294a90ad471
SPL ID: 2c3d4146-03d9-30a9-e063-6294a90ad471
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: CIPROFLOXACIN
Generic name: CIPROFLOXACIN
Dosage form: TABLET, COATED
Route: ORAL
Marketing start: 2022-02-21
Marketing category: ANDA
Application number: ANDA208921
Pharmacologic classes: Cytochrome P450 1A2 Inhibitors [MoA]; Fluoroquinolone Antibacterial [EPC]; Fluoroquinolones [CS]
Listing expiration: 2026-12-31

Ingredient	Strength
CIPROFLOXACIN HYDROCHLORIDE	250 mg/1

Package NDC	Description	Marketing start	Sample
72189-323-06	6 TABLET, COATED in 1 BOTTLE (72189-323-06)	2022-02-21	No

UNII	Preferred term	Registry number	Matched term
4BA73M5E37	CIPROFLOXACIN HYDROCHLORIDE	86393-32-0	CIPROFLOXACIN HYDROCHLORIDE
5E8K9I0O4U	CIPROFLOXACIN	85721-33-1	CIPROFLOXACIN

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-323-06	72189032306	6 TABLET, COATED in 1 BOTTLE (72189-323-06)	2022-02-21	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin	Direct Rx	2025-01-21	HUMAN PRESCRIPTION DRUG LABEL	2