levocarnitine
- Product NDC
- 68083-681
- 11-digit product format
- 680830681
- Labeler code
- 68083
- Product ID
- 68083-681_e5af94a7-f7f4-40c8-aaef-f615df275e60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocarnitine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA220181
- Marketing category
- ANDA
- Marketing start
- 2026-09-30
- Substance
- LEVOCARNITINE
- Active strength
- 1 g/5mL
- Pharmacologic classes
- Carnitine Analog [EPC], Carnitine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- levocarnitine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVOCARNITINE | 1 g/5mL |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-681-05 | 68083068105 | 5 VIAL, SINGLE-DOSE in 1 CARTON (68083-681-05) / 5 mL in 1 VIAL, SINGLE-DOSE | 2026-09-30 | No | No | Current |