LEVOFLOXACIN
- Product NDC
- 42571-168
- 11-digit product format
- 425710168
- Labeler code
- 42571
- Product ID
- 42571-168_833c5e2e-8b64-3b8f-e053-2a91aa0ab453
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Micro Labs Limited
- Application
- ANDA205600
- Marketing category
- ANDA
- Marketing start
- 2019-04-16
- Substance
- LEVOFLOXACIN
- Active strength
- 15 mg/mL
- 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 | 15 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GNT3Y5LMF |
| Rxcui | 545118 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-168-25 | LEVOFLOXACIN | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 6 |
| 42571-168-25 | LEVOFLOXACIN | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-168 | LEVOFLOXACIN (LEVOFLOXACIN) SOLUTION/ DROPS [MICRO LABS LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20190416_c0417827-3c49-4dbd-97a8-3e2bb509d157.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 |
|---|
| 42571-168-25 | 42571016825 | 1 BOTTLE in 1 CARTON (42571-168-25) / 5 mL in 1 BOTTLE | 1 bottle | 2019-04-16 | 0000-00-00 | No | No | Current |