Levofloxacin
- Product NDC
- 65862-538
- 11-digit product format
- 658620538
- Labeler code
- 65862
- Product ID
- 65862-538_00620274-6cae-4cb8-bd5d-8f80732ae3ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA201043
- Marketing category
- ANDA
- Marketing start
- 2011-06-20
- Substance
- LEVOFLOXACIN
- Active strength
- 750 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levofloxacin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVOFLOXACIN | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GNT3Y5LMF |
| Rxcui | 199884, 199885, 311296 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-538-05 | Levofloxacin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 23 |
| 65862-538-10 | Levofloxacin | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 23 |
| 65862-538-10 | Levofloxacin | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 23 |
| 65862-538-20 | Levofloxacin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 23 |
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.] | 7 | |
| LEVOFLOXACIN | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| LEVOFLOXACIN ANHYDROUS | ACTIVE MOIETY | RIX4E89Y14 | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| LEVOFLOXACIN ANHYDROUS | ACTIVE MOIETY | RIX4E89Y14 | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-538 | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 23 | Current NDC, Legacy NDC, 4 package rows | 20240630_529ac72c-c4a0-4001-8cf9-b94f5bf7265c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-538-05 | 65862053805 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-538-05) | | 2011-06-20 | 0000-00-00 | No | No | Current |
| 65862-538-10 | 65862053810 | 10 BLISTER PACK in 1 CARTON (65862-538-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2011-06-20 | 0000-00-00 | No | No | Current |
| 65862-538-20 | 65862053820 | 20 TABLET, FILM COATED in 1 BOTTLE (65862-538-20) | | 2011-06-20 | 0000-00-00 | No | No | Current |
| 65862-538-29 | 65862053829 | 20000 TABLET, FILM COATED in 1 BAG (65862-538-29) | | 07-JAN-22 | | | | Current |
| 65862-538-99 | 65862053899 | 1000 TABLET, FILM COATED in 1 BAG (65862-538-99) | | 20-JUN-11 | | | | Current |