Levofloxacin
- Product NDC
- 21695-041
- 11-digit product format
- 216950041
- Labeler code
- 21695
- Product ID
- 21695-041_f82ee9e3-5119-4be0-883c-5831386baef6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA076361
- Marketing category
- ANDA
- Marketing start
- 2011-06-20
- Marketing end
- 0000-00-00
- Substance
- LEVOFLOXACIN
- Active strength
- 750 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-041-05 | Levofloxacin | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 3 |
| 21695-041-10 | Levofloxacin | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOFLOXACIN | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| LEVOFLOXACIN | ACTIVE MOIETY | 6GNT3Y5LMF | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-041 | LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 3 | Legacy NDC, 2 package rows | 20120511_312e65cb-897f-4c24-b17b-be7e8ce469bb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-041-05 | 21695004105 | 5 in 1 BOTTLE | Historical |
| 21695-041-10 | 21695004110 | 10 in 1 BOTTLE | Historical |