ofloxacin

Product NDC: 68047-713
11-digit product format: 680470713
Labeler code: 68047
Product ID: 68047-713_ee14f649-d36a-8131-e053-2a95a90ac0b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Larken Laboratories, Inc.
Application: ANDA076093
Marketing category: ANDA
Marketing start: 2014-05-20
Marketing end: 2023-05-31
Substance: OFLOXACIN
Active strength: 400 mg/1
Pharmacologic classes: Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68047-713-01	2021-10-19	C162847	48780-1	ba0f9c33-1248-a910-e053-dadaa90a0b85	6a3dcc79-bde4-4c32-8a0e-ea14a1e1a191
68047-713-01	2021-01-29	C162847	48780-1	ba0f9c33-1248-a910-e053-dadaa90a0b85	6a3dcc79-bde4-4c32-8a0e-ea14a1e1a191

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68047-713-01	EA - Each	68047-713	7f5e3b89-b25f-4866-980b-eeb311a0c571	1	2015-09-10
68047-713-20	EA - Each	68047-713	4089ed1d-907d-400c-8dde-75a0cf14b679	1	2021-07-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68047-713-20	68047071320	20 TABLET, FILM COATED in 1 BOTTLE (68047-713-20)	2021-06-15	0000-00-00	No	No	Current