Levofloxacin
- Product NDC
- 72789-085
- 11-digit product format
- 727890085
- Labeler code
- 72789
- Product ID
- 72789-085_40319459-b17c-0929-e063-6294a90acf2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA201043
- Marketing category
- ANDA
- Marketing start
- 2011-06-20
- Substance
- LEVOFLOXACIN
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GNT3Y5LMF |
| Rxcui | 199885 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-085-50 | Levofloxacin | 50 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 50 | | 30 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-085 | LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 29 | Current NDC, Legacy NDC, 1 package rows | 20241127_b8defac4-9deb-433b-928e-0ef4ee0123a2.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 |
|---|
| 72789-085-50 | 72789008550 | 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-085-50) | 2020-06-16 | 0000-00-00 | No | No | Current |