Lacosamide Oral Solution

Product NDC: 73190-103
11-digit product format: 731900103
Labeler code: 73190
Product ID: 73190-103_5b10986e-080a-b6d1-e063-6394a90a5738
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lacosamide
Dosage form: SOLUTION
Route: ORAL
Labeler: AvKARE
Application: ANDA219699
Marketing category: ANDA
Marketing start: 2026-09-09
Substance: LACOSAMIDE
Active strength: 10 mg/mL
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A219699-001	LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA		2025-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219699-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A219699-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2025-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219699-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2025-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219699-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2025-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219699-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2025-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219699-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2025-06-26	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219699-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2025-06-26	`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	A219699-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219699-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219699-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219699-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219699-001	AA	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219699-001	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Lacosamide Oral Solution
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LACOSAMIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
563KS2PQY5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993856	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5b10986e-0809-b6d1-e063-6394a90a5738	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lacosamide Oral Solution	LACOSAMIDE	AvKARE	5b10986e-0809-b6d1-e063-6394a90a5738	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219699 application number: ANDA219699 ndc (product): 73190-103
Lacosamide Oral Solution	LACOSAMIDE	Ajenat Pharmaceuticals LLC	cb29da34-89aa-405a-8fbc-2308bda37187	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219699 application number: ANDA219699
Lacosamide Oral Solution	LACOSAMIDE	Kesin Pharma Corporation	446f14be-5d79-26b9-e063-6294a90ae0b5	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219699 application number: ANDA219699
Lacosamide Oral Solution	LACOSAMIDE	Kesin Pharmaceutical Corporation	3ba29442-4e8a-c2b2-e063-6294a90a1bbf	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219699 application number: ANDA219699

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
563KS2PQY5	LACOSAMIDE	175481-36-4	LACOSAMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73190-103-20	73190010320	200 mL in 1 BOTTLE (73190-103-20)	200 ml	2026-09-09	No	No	Current