levofloxacin
- Product NDC
- 65841-693
- 11-digit product format
- 658410693
- Labeler code
- 65841
- Product ID
- 65841-693_5aeae448-e53f-4954-9dd9-2bcc3dd791d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA077652
- Marketing category
- ANDA
- Marketing start
- 2012-11-10
- 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 |
|---|
| 65841-693-01 | levofloxacin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 11 |
| 65841-693-05 | levofloxacin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
| 65841-693-06 | levofloxacin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 11 |
| 65841-693-18 | levofloxacin | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 11 |
| 65841-693-92 | levofloxacin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOFLOXACIN | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVOFLOXACIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| LEVOFLOXACIN ANHYDROUS | ACTIVE MOIETY | RIX4E89Y14 | LEVOFLOXACIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOFLOXACIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LEVOFLOXACIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVOFLOXACIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOFLOXACIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | LEVOFLOXACIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVOFLOXACIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOFLOXACIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-693 | LEVOFLOXACIN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 11 | Current NDC, Legacy NDC, 5 package rows | 20240821_ffa121b8-388f-4d7b-af48-d4aa8d9b5961.zip |
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 |
|---|
| 65841-693-01 | 65841069301 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-693-01) | 2012-11-10 | 0000-00-00 | No | No | Current |
| 65841-693-05 | 65841069305 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-693-05) | 2012-11-10 | 0000-00-00 | No | No | Current |
| 65841-693-06 | 65841069306 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-693-06) | 2022-01-10 | 0000-00-00 | No | No | Current |
| 65841-693-18 | 65841069318 | 50 TABLET, FILM COATED in 1 BOTTLE (65841-693-18) | 2012-11-10 | 0000-00-00 | No | No | Current |
| 65841-693-92 | 65841069392 | 20 TABLET, FILM COATED in 1 BOTTLE (65841-693-92) | 2022-01-10 | 0000-00-00 | No | No | Current |