ofloxacin

Product NDC: 68047-713
Requested package NDC: 68047-713-20
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68047-713	68047-713-20	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076093-001	OFLOXACIN	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02
A076093-002	OFLOXACIN	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02
A076093-003	OFLOXACIN	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076093-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A076093-003	AB	1	`a50c72e98297…`

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	OFLOXACIN TABLETS 400 mg Rx Only
68047-713-01	2021-01-29	C162847	48780-1	ba0f9c33-1248-a910-e053-dadaa90a0b85	OFLOXACIN TABLETS 400 mg Rx Only

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OFLOXACIN	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN TABLET, FILM COATED [LARKEN LABORATORIES, INC.]	1
OFLOXACIN	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN TABLET, FILM COATED [LARKEN LABORATORIES, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	OFLOXACIN TABLET, FILM COATED [LARKEN LABORATORIES, INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	OFLOXACIN TABLET, FILM COATED [LARKEN LABORATORIES, INC.]	1
HYPROMELLOSE 2208 (3 MPA.S)	INACTIVE INGREDIENT	9H4L916OBU	OFLOXACIN TABLET, FILM COATED [LARKEN LABORATORIES, INC.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	OFLOXACIN TABLET, FILM COATED [LARKEN LABORATORIES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OFLOXACIN TABLET, FILM COATED [LARKEN LABORATORIES, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	OFLOXACIN TABLET, FILM COATED [LARKEN LABORATORIES, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	OFLOXACIN TABLET, FILM COATED [LARKEN LABORATORIES, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	OFLOXACIN TABLET, FILM COATED [LARKEN LABORATORIES, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OFLOXACIN TABLET, FILM COATED [LARKEN LABORATORIES, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OFLOXACIN TABLET, FILM COATED [LARKEN LABORATORIES, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A4P49JAZ9H	OFLOXACIN	82419-36-1	OFLOXACIN

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)	2020-08-19	2023-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OFLOXACIN TABLETS 400 mg Rx Only	Larken Laboratories, Inc.	2022-11-22	HUMAN PRESCRIPTION DRUG LABEL	11
OFLOXACIN TABLETS 400 mg Rx Only	Larken Laboratories, Inc.	2019-05-30	HUMAN PRESCRIPTION DRUG LABEL	8