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 42 .
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 2026-08-18 06:07:40 2026-07 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 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…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212533-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2021-11-10 a50c72e98297…
Observed Orange Book normalized TE history# 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
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 · 2 matching rows.
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