FDA.reportPublic FDA data

Lacosamide Oral Solution

Product NDC
81033-427
Requested package NDC
81033-427-17
11-digit product format
810330427
Labeler code
81033
Product ID
81033-427_3ba29442-4e8b-c2b2-e063-6294a90a1bbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
Kesin Pharmaceutical Corporation
Application
ANDA219699
Marketing category
ANDA
Marketing start
2025-08-05
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
2026-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219699-001LACOSAMIDELACOSAMIDE10MG/MLSOLUTION / ORALAA2025-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219699-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219699-001LACOSAMIDE10MG/MLSOLUTION / ORALAA2025-06-2684e616aacf4f…
2026-08-18 06:07:402026-07A219699-001LACOSAMIDE10MG/MLSOLUTION / ORALAA2025-06-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219699-001LACOSAMIDE10MG/MLSOLUTION / ORALAA2025-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219699-001LACOSAMIDE10MG/MLSOLUTION / ORALAA2025-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A219699-001LACOSAMIDE10MG/MLSOLUTION / ORALAA2025-06-266a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219699-001LACOSAMIDE10MG/MLSOLUTION / ORALAA2025-06-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219699-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A219699-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219699-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219699-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219699-001AA16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219699-001AA1a50c72e98297…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACOSAMIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
563KS2PQY5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ba29442-4e8a-c2b2-e063-6294a90a1bbfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-427-05Lacosamide Oral Solution5 mL in 1 CUP, UNIT-DOSESOLUTION51
81033-427-10Lacosamide Oral Solution10 mL in 1 CUP, UNIT-DOSESOLUTION101
81033-427-14Lacosamide Oral Solution10 in 1 CARTONSOLUTION101
81033-427-15Lacosamide Oral Solution15 mL in 1 CUP, UNIT-DOSESOLUTION151
81033-427-16Lacosamide Oral Solution10 in 1 CARTONSOLUTION101
81033-427-17Lacosamide Oral Solution10 in 1 CARTONSOLUTION101
81033-427-18Lacosamide Oral Solution10 in 1 CARTONSOLUTION101
81033-427-20Lacosamide Oral Solution20 mL in 1 CUP, UNIT-DOSESOLUTION201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-427-05ML - Milliliter81033-4272d3d530a-15f2-4d4d-9e5d-f710122063ab12025-12-16
81033-427-10ML - Milliliter81033-427e7759c3a-f29e-436d-a32b-d8bc4391979412025-12-16
81033-427-14ML - Milliliter81033-42789afc664-5f8c-4f57-b098-6b73f9d090e012025-12-16
81033-427-15ML - Milliliter81033-427eb72a5ff-67c1-477c-aeda-b046b4c26a2a12026-03-17
81033-427-16ML - Milliliter81033-427b7dd91a8-307a-419e-ba67-9d10de53a4fc12025-12-16
81033-427-17ML - Milliliter81033-4275f9c12cb-f676-4679-9ec8-57f0c582724e12026-03-17
81033-427-18ML - Milliliter81033-42791e5225d-fa6e-4957-baa4-8e02b112b84712026-03-17
81033-427-20ML - Milliliter81033-4276d36b226-34e6-4c4e-a8c2-cf3af3bbebdc12026-03-17

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lacosamide Oral SolutionLACOSAMIDEAvKARE5b10986e-0809-b6d1-e063-6394a90a57382026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219699
application number: ANDA219699
Lacosamide Oral SolutionLACOSAMIDEAjenat Pharmaceuticals LLCcb29da34-89aa-405a-8fbc-2308bda371872025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219699
application number: ANDA219699
Lacosamide Oral SolutionLACOSAMIDEKesin Pharma Corporation446f14be-5d79-26b9-e063-6294a90ae0b52025-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219699
application number: ANDA219699
Lacosamide Oral SolutionLACOSAMIDEKesin Pharmaceutical Corporation3ba29442-4e8a-c2b2-e063-6294a90a1bbf2025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219699
application number: ANDA219699
ndc (package): 81033-427-17
ndc (product): 81033-427
ndc11 (package): 81033042717

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993856lacosamide 10 MG in 1 mL Oral SolutionPSN3ba29442-4e8a-c2b2-e063-6294a90a1bbf1
993856lacosamide 10 MG/ML Oral SolutionSCD3ba29442-4e8a-c2b2-e063-6294a90a1bbf1
993856lacosamide 10 MG per 1 ML Oral SolutionSY3ba29442-4e8a-c2b2-e063-6294a90a1bbf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81033-427-178103304271710 CUP, UNIT-DOSE in 1 CARTON (81033-427-17) / 15 mL in 1 CUP, UNIT-DOSE (81033-427-15) 2025-08-05NoNoCurrent