Levocarnitine
- Product NDC
- 0517-1045
- 11-digit product format
- 005171045
- Labeler code
- 0517
- Product ID
- 0517-1045_114eaeda-8965-4c92-a3ff-15021b305464
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levocarnitine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- American Regent, Inc.
- Application
- ANDA075861
- Marketing category
- ANDA
- Marketing start
- 2023-06-21
- Substance
- LEVOCARNITINE
- Active strength
- 200 mg/mL
- Pharmacologic classes
- Carnitine Analog [EPC], Carnitine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levocarnitine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVOCARNITINE | 200 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0G389FZZ9M |
| Rxcui | 1791371, 2673428 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0517-1045-01 | Levocarnitine | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 11 |
| 0517-1045-05 | Levocarnitine | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOCARNITINE | ACTIVE INGREDIENT | 0G389FZZ9M | LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 4 | |
| LEVOCARNITINE | ACTIVE MOIETY | 0G389FZZ9M | LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 4 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-1045 | LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240123_cc4da2c3-f939-444d-9b5b-a57b6051c190.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 |
|---|
| 0517-1045-01 | 00517104501 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | | Historical |
| 0517-1045-05 | 00517104505 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1045-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-1045-01) | | 2023-06-21 | | No | No | Historical |
| 0517-1045-25 | 00517104525 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-1045-25) > 5 mL in 1 VIAL, SINGLE-DOSE | | 2001-10-08 | 0000-00-00 | No | No | Current |