Home NDC 71656-016 Levocarnitine
Product NDC 71656-016
11-digit product format 716560016
Labeler code 71656
Product ID 71656-016_30a343cc-caab-d417-e063-6394a90ad77b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levocarnitine Oral
Dosage form SOLUTION
Route ORAL
Labeler Saptalis Pharmaceuticals, LLC
Application ANDA212533
Marketing category ANDA
Marketing start 2024-02-21
Substance LEVOCARNITINE
Active strength 1 g/10mL
Pharmacologic classes Carnitine Analog [EPC], Carnitine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A212533-001 LEVOCARNITINE LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212533-001 AA
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 2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 cb3db0bc1861…2026-08-01 22:54:32 2026-06 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Levocarnitine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOCARNITINE 1 g/10mL
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 315134 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71656-016-01 Levocarnitine 100 in 1 TRAY SOLUTION 100 4 71656-016-02 Levocarnitine 100 in 1 TRAY SOLUTION 100 4 71656-016-04 Levocarnitine 118 mL in 1 BOTTLE SOLUTION 118 4 71656-016-05 Levocarnitine 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 4 71656-016-10 Levocarnitine 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 4 71656-016-50 Levocarnitine 50 in 1 TRAY SOLUTION 50 4 71656-016-51 Levocarnitine 50 in 1 TRAY SOLUTION 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71656-016 LEVOCARNITINE (LEVOCARNITINE ORAL) SOLUTION [SAPTALIS PHARMACEUTICALS, LLC] 4 Current NDC, 7 package rows 20250321_75b43fb1-4486-48a0-b571-7754dce350a3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71656-016-01 71656001601 100 CUP, UNIT-DOSE in 1 TRAY (71656-016-01) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05) 2024-02-21 No No Current 71656-016-02 71656001602 100 CUP, UNIT-DOSE in 1 TRAY (71656-016-02) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10) 2024-02-21 No No Current 71656-016-04 71656001604 118 mL in 1 BOTTLE (71656-016-04) 118 ml 2024-02-21 No No Current 71656-016-05 71656001605 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 71656-016-10 71656001610 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 71656-016-50 71656001650 50 CUP, UNIT-DOSE in 1 TRAY (71656-016-50) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05) 2024-02-21 No No Current 71656-016-51 71656001651 50 CUP, UNIT-DOSE in 1 TRAY (71656-016-51) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10) 2024-02-21 No No Current