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
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 68047-713 | | D | Discontinued by firm | | 2026-07-31 |
| excluded product | product | 68047-713 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 68047-713 | 68047-713-01 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 68047-713 | 68047-713-20 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | 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#
Application-product, TE code table| Application-product | TE code |
|---|
| A076093-003 | AB |
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| 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 | |
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 |