Levofloxacin
- Product NDC
- 50383-286
- 11-digit product format
- 503830286
- Labeler code
- 50383
- Product ID
- 50383-286_11805cbd-316b-41f6-bf82-e7af2889e563
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Akorn
- Application
- ANDA091678
- Marketing category
- ANDA
- Marketing start
- 2011-06-21
- Marketing end
- 0000-00-00
- Substance
- LEVOFLOXACIN
- Active strength
- 25 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOFLOXACIN | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.] | 11 | |
| LEVOFLOXACIN ANHYDROUS | ACTIVE MOIETY | RIX4E89Y14 | LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.] | 11 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.] | 11 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.] | 11 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.] | 11 | |
| GRAPE | INACTIVE INGREDIENT | 6X543N684K | LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.] | 11 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.] | 11 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.] | 11 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.] | 11 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.] | 11 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.] | 11 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-286 | LEVOFLOXACIN SOLUTION [AKORN] | 27 | Legacy NDC, 12 package rows | 20221103_c6c7322b-6a89-4d23-90d1-bf9327bd6d91.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 |
|---|
| 50383-286-04 | 50383028604 | 1 BOTTLE in 1 CARTON (50383-286-04) > 100 mL in 1 BOTTLE | 1 bottle | 2011-06-21 | 0000-00-00 | No | No | Current |
| 50383-286-08 | 50383028608 | 1 BOTTLE in 1 CARTON (50383-286-08) > 200 mL in 1 BOTTLE | 1 bottle | 2011-06-21 | 0000-00-00 | No | No | Current |
| 50383-286-10 | 50383028610 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | | Historical |
| 50383-286-11 | 50383028611 | 4 TRAY in 1 CASE (50383-286-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-286-10) | 4 tray | 2015-02-11 | 0000-00-00 | No | No | Current |
| 50383-286-16 | 50383028616 | 1 BOTTLE in 1 CARTON (50383-286-16) > 480 mL in 1 BOTTLE | 1 bottle | 2011-06-21 | 0000-00-00 | No | No | Current |
| 50383-286-20 | 50383028620 | 20 mL in 1 CUP, UNIT-DOSE | 20 ml | | | | | Historical |
| 50383-286-21 | 50383028621 | 4 TRAY in 1 CASE (50383-286-21) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-286-20) | 4 tray | 2015-02-11 | 0000-00-00 | No | No | Current |