Home NDC 16571-762 Levocarnitine
Product NDC 16571-762
11-digit product format 165710762
Labeler code 16571
Product ID 16571-762_ad6d92d4-71c1-481a-a7cf-b2d551c5daad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levocarnitine
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA076858
Marketing category ANDA
Marketing start 2020-12-01
Substance LEVOCARNITINE
Active strength 330 mg/1
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 A076858-001 LEVOCARNITINE LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076858-001 AB
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.
Product history page 1 of 2 · 42 observed 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 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Levocarnitine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOCARNITINE 330 mg/1
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 197448 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 16571-762-09 Levocarnitine 9 in 1 CARTON TABLET 9 3 16571-762-09 Levocarnitine 10 in 1 BLISTER PACK TABLET 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-762 LEVOCARNITINE TABLET [RISING PHARMA HOLDINGS, INC.] 3 Current NDC, 2 package rows 20240927_0f749812-8f02-4eeb-91d9-5dd6fc9fa159.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 · 1 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 16571-762-09 16571076209 9 BLISTER PACK in 1 CARTON (16571-762-09) / 10 TABLET in 1 BLISTER PACK 9 blister pack 2020-12-01 No No Current