levofloxacin
- Product NDC
- 68382-016
- 11-digit product format
- 683820016
- Labeler code
- 68382
- Product ID
- 68382-016_6aba6a7e-43d3-41b0-bdc0-a62ffb483919
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA077652
- Marketing category
- ANDA
- Marketing start
- 2012-11-10
- Marketing end
- 0000-00-00
- Substance
- LEVOFLOXACIN
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOFLOXACIN | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 8 | |
| LEVOFLOXACIN ANHYDROUS | ACTIVE MOIETY | RIX4E89Y14 | LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 8 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 8 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 8 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 8 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 8 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-016-01 | 68382001601 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-016-01) | 2012-11-10 | 0000-00-00 | No | No | Current |
| 68382-016-05 | 68382001605 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-016-05) | 2012-11-10 | 0000-00-00 | No | No | Current |
| 68382-016-10 | 68382001610 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-016-10) | 2012-11-10 | 0000-00-00 | No | No | Current |
| 68382-016-18 | 68382001618 | 50 TABLET, FILM COATED in 1 BOTTLE (68382-016-18) | 2012-11-10 | 0000-00-00 | No | No | Current |