Levofloxacin
- Product NDC
- 31722-721
- 11-digit product format
- 317220721
- Labeler code
- 31722
- Product ID
- 31722-721_1fa0a846-34d8-d6f5-e063-6394a90a8e54
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA202801
- Marketing category
- ANDA
- Marketing start
- 2015-01-09
- Substance
- LEVOFLOXACIN
- Active strength
- 250 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 | 250 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 |
|---|
| 31722-721-31 | Levofloxacin | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 9 |
| 31722-721-32 | Levofloxacin | 100 in 1 BLISTER PACK | TABLET, FILM COATED | 100 | | 9 |
| 31722-721-50 | Levofloxacin | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOFLOXACIN | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| LEVOFLOXACIN ANHYDROUS | ACTIVE MOIETY | RIX4E89Y14 | LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-721 | LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 3 package rows | 20240815_b43e9b51-568c-4d84-bbd1-d237120056c4.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 |
|---|
| 31722-721-31 | 31722072131 | 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-721-31) | 2015-01-09 | 0000-00-00 | No | No | Current |
| 31722-721-32 | 31722072132 | 100 TABLET, FILM COATED in 1 BLISTER PACK (31722-721-32) | 2015-01-09 | 0000-00-00 | No | No | Current |
| 31722-721-50 | 31722072150 | 50 TABLET, FILM COATED in 1 BOTTLE (31722-721-50) | 2015-01-09 | 0000-00-00 | No | No | Current |