Levofloxacin
- Product NDC
- 43063-637
- 11-digit product format
- 430630637
- Labeler code
- 43063
- Product ID
- 43063-637_efe3dfa7-34d1-fd19-e053-2995a90a27d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA200839
- Marketing category
- ANDA
- Marketing start
- 2012-03-22
- Marketing end
- 0000-00-00
- Substance
- LEVOFLOXACIN
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOFLOXACIN | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 10 | |
| LEVOFLOXACIN ANHYDROUS | ACTIVE MOIETY | RIX4E89Y14 | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 10 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 10 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 10 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 10 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 10 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 10 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 10 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-637 | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 22 | Legacy NDC | 20241013_246fcec2-d7ac-2e29-e054-00144ff88e88.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-637-10 | 43063063710 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-637-10) | 2015-11-16 | 0000-00-00 | No | No | Current |