LEVAQUIN
- Product NDC
- 67296-0372
- 11-digit product format
- 672960372
- Labeler code
- 67296
- Product ID
- 67296-0372_9ee3191e-6836-4324-892c-1ccd55baf473
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RedPharm Drug Inc.
- Application
- NDA020634
- Marketing category
- NDA
- Marketing start
- 1996-12-20
- Marketing end
- 0000-00-00
- Substance
- LEVOFLOXACIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Quinolone Antimicrobial [EPC],Quinolones [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 67296-0372-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d29e-8e05-e053-dbdaa90a074a | These highlights do not include all the information needed to use LEVAQUIN ® safely and effectively. See full prescribing information for LEVAQUIN. LEVAQUIN ® (levofloxacin) Tablet, Film Coated for Oral use LEVAQUIN ® (levofloxacin) Solution for Oral use LEVAQUIN ® (levofloxacin) Injection, Solution, Concentrate for Intravenous use LEVAQUIN ® (levofloxacin) Injection, Solution for Intravenous use Initial U.S. Approval: 1996 |
| 67296-0372-2 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d29e-8e05-e053-dbdaa90a074a | These highlights do not include all the information needed to use LEVAQUIN ® safely and effectively. See full prescribing information for LEVAQUIN. LEVAQUIN ® (levofloxacin) Tablet, Film Coated for Oral use LEVAQUIN ® (levofloxacin) Solution for Oral use LEVAQUIN ® (levofloxacin) Injection, Solution, Concentrate for Intravenous use LEVAQUIN ® (levofloxacin) Injection, Solution for Intravenous use Initial U.S. Approval: 1996 |
| 67296-0372-3 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d29e-8e05-e053-dbdaa90a074a | These highlights do not include all the information needed to use LEVAQUIN ® safely and effectively. See full prescribing information for LEVAQUIN. LEVAQUIN ® (levofloxacin) Tablet, Film Coated for Oral use LEVAQUIN ® (levofloxacin) Solution for Oral use LEVAQUIN ® (levofloxacin) Injection, Solution, Concentrate for Intravenous use LEVAQUIN ® (levofloxacin) Injection, Solution for Intravenous use Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67296-0372-1 | LEVAQUIN | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 2 |
| 67296-0372-2 | LEVAQUIN | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 2 |
| 67296-0372-3 | LEVAQUIN | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| levofloxacin | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.] | 2 | |
| levofloxacin | ACTIVE MOIETY | 6GNT3Y5LMF | LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.] | 2 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.] | 2 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.] | 2 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.] | 2 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.] | 2 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.] | 2 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.] | 2 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.] | 2 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67296-0372 | LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.] | 2 | Legacy NDC, 3 package rows | 20110729_40a96527-f89e-4177-9224-5c79167f3e60.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 67296-0372-1 | 67296037201 | 10 in 1 BOTTLE | Historical |
| 67296-0372-2 | 67296037202 | 7 in 1 BOTTLE | Historical |
| 67296-0372-3 | 67296037203 | 5 in 1 BOTTLE | Historical |