Home NDC 36000-368 LEVOCARNITINE
Product NDC 36000-368
11-digit product format 360000368
Labeler code 36000
Product ID 36000-368_1f38ab0d-ef89-4e92-990f-9da190057e17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVOCARNITINE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA217896
Marketing category ANDA
Marketing start 2026-07-02
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 43 .
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 A217896-001 LEVOCARNITINE LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2026-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217896-001 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 2026-09-14 22:38:34 2026-08 A217896-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2026-07-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217896-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2026-07-02 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217896-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2026-07-02 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A217896-001 AP 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217896-001 AP 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217896-001 AP 1 a50c72e98297…
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0G389FZZ9M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791371 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 36000-368-10 36000036810 10 VIAL, SINGLE-DOSE in 1 CARTON (36000-368-10) / 5 mL in 1 VIAL, SINGLE-DOSE (36000-368-01) 2026-07-02 No No Current