Levofloxacin
- Product NDC
- 55154-5897
- 11-digit product format
- 551545897
- Labeler code
- 55154
- Product ID
- 55154-5897_0337130d-797d-4dcf-834c-ed1eda1e77d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA076710
- Marketing category
- ANDA
- Marketing start
- 2013-12-01
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVOFLOXACIN | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GNT3Y5LMF |
| Rxcui | 199885, 311296 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-5897-0 | Levofloxacin | 10 in 1 BAG | TABLET, FILM COATED | 10 | | 18 |
| 55154-5897-0 | Levofloxacin | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOFLOXACIN | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
| LEVOFLOXACIN ANHYDROUS | ACTIVE MOIETY | RIX4E89Y14 | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-5897 | LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 17 | Current NDC, Legacy NDC, 2 package rows | 20250312_070375be-3b67-4299-ae8f-4a7b157ac16f.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 |
|---|
| 55154-5897-0 | 55154589700 | 10 BLISTER PACK in 1 BAG (55154-5897-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2013-12-01 | 0000-00-00 | No | No | Current |