LACOSAMIDE injection, for intravenous use, CV

Manufacturer: Zydus Lifesciences Limited
Effective date: 2023-10-03
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 20:53:39

Label at a glance#

ProductLACOSAMIDE

Active ingredientLACOSAMIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1682-1

Lacosamide Injection, USP 200 mg/20 mL (10 mg/mL); CV

For Intravenous Use Only

20 mL single-dose vial

Rx only

NDC 70771-1682-6

Lacosamide Injection, USP 200 mg/20 mL (10 mg/mL); CV

For Intravenous Use Only

10 X 20 mL Single-dose vials

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
809974	lacosamide 200 MG in 20 ML Injection	PSN	2
809974	20 ML lacosamide 10 MG/ML Injection	SCD	2
809974	lacosamide 200 MG per 20 ML Injection	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LACOSAMIDE Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20210712

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fac83aa9-21ef-4152-b501-369c0bc4765b	Product name	1	20231010
c8c500b5-16db-e0e3-fdf1-c683d7be70e3	Product name	3	20161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70771-1682-1	LACOSAMIDE	20 mL in 1 VIAL	INJECTION	20		2
70771-1682-6	LACOSAMIDE	10 in 1 CARTON	INJECTION	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1682	LACOSAMIDE INJECTION [ZYDUS LIFESCIENCES LIMITED]	2	Current NDC, Legacy NDC, 2 package rows	20231005_3bc84c70-bc1d-4a72-bbe7-86f32cd646d0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

LACOSAMIDE
HYDROCHLORIC ACID
SODIUM CHLORIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1682	70771-1682-1, 70771-1682-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACOSAMIDE	563KS2PQY5	ACTIB
HYDROCHLORIC ACID	QTT17582CB	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209465-001	LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A209465-001	AP

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209465-001	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-06-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209465-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209465-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209465-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209465-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209465-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209465-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209465-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209465-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209465-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209465-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209465-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209465-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209465-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209465-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209465-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209465-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209465-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209465-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209465-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209465-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209465-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209465-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209465-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209465-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209465-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209465-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209465-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209465-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209465-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209465-001	AP	1	`a50c72e98297…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LACOSAMIDE	LACOSAMIDE	Zydus Lifesciences Limited	3bc84c70-bc1d-4a72-bbe7-86f32cd646d0	2023-10-03		Exact identifier ndc (package): 70771-1682-6 ndc (package): 70771-1682-1 ndc (product): 70771-1682 ndc11 (package): 70771168201 ndc11 (package): 70771168206 spl id: 96b87696-5bfd-4306-b00e-c66e7b93f071 spl set id: 3bc84c70-bc1d-4a72-bbe7-86f32cd646d0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.