Home NDC 70954-139 Levocarnitine
Product NDC 70954-139
11-digit product format 709540139
Labeler code 70954
Product ID 70954-139_83851536-e1cf-4353-af71-abe714a48c9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levocarnitine
Dosage form SOLUTION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA211676
Marketing category ANDA
Marketing start 2019-08-14
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211676-001 LEVOCARNITINE LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 A211676-002 LEVOCARNITINE SF LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 64 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 2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 d8e5a09893c0…2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211676-001 LEVOCARNITINE 1GM/10ML SOLUTION / ORAL AA 2019-08-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A211676-002 LEVOCARNITINE SF 1GM/10ML SOLUTION / ORAL AA 2019-08-14 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
Observed Orange Book exclusivity 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 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 70954-139-10 Levocarnitine 118 mL in 1 BOTTLE SOLUTION 118 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-139 LEVOCARNITINE SOLUTION [ANI PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20240522_18dc8eae-56c1-46ec-9d21-e17d7b2f91db.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70954-139-10 70954013910 118 mL in 1 BOTTLE (70954-139-10) 118 ml 2019-08-14 0000-00-00 No No Current