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 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 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.
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 2024-10-29 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 cb3db0bc1861…2026-08-01 22:54:32 2026-06 A076858-001 LEVOCARNITINE 330MG TABLET / ORAL AB 2004-09-20 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 · 1 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 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
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