Home NDC 68083-681 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 · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220181-001 LEVOCARNITINE LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2026-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220181-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A220181-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2026-09-30 c2088c7a36db…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A220181-001 AP 1 c2088c7a36db…
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