What is NDC 51991-350?

51991-350 is the product NDC for Lacosamide, Lacosamide 150 mg/1 tablet, film coated, listed with the FDA by Breckenridge Pharmaceutical, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lacosamide?

146 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lacosamide NDC 51991-350 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51991-350Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51991-0350Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
51991-350-05	5199103500551991035005	500 TABLET, FILM COATED in 1 BOTTLE (51991-350-05)Marketed from Mar 18, 2022
51991-350-06	5199103500651991035006	60 TABLET, FILM COATED in 1 BOTTLE (51991-350-06)Marketed from Mar 18, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Lacosamide
Generic name (nonproprietary): lacosamide
Active ingredients: Lacosamide — 150 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204921
Marketing start: Mar 18, 2022
Listing expires: Dec 31, 2027
DEA schedule: CV
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 51991-350_d59d1657-c847-475f-998d-49d186f6697eSPL ID d59d1657-c847-475f-998d-49d186f6697eSPL set ID f7ea3ce6-4ca7-4405-a011-48e7d71360a5RxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N451991035005 followed by a unit qualifier and the quantity

Package 51991-0350-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Sep 12, 2024.

Indications (excerpt from the label)

Lacosamide tablets are indicated for: Treatment of partial-onset seizures in patients 4 years of age and older ( 1.1 ) 1.1 Partial-Onset Seizures Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.'s VIMPAT ® (lacosamide) tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51991-350

What is NDC 51991-350?: 51991-350 is the product NDC for Lacosamide, Lacosamide 150 mg/1 tablet, film coated, listed with the FDA by Breckenridge Pharmaceutical, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lacosamide.
What is the active ingredient?: Lacosamide.
Who is the labeler?: Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lacosamide?: 146 other product NDCs are listed under this name. See all Lacosamide NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lacosamide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lacosamide	Lacosamide 50 mg/1	TabletOral	AvPAK	50268-491	50268-0491-10
Lacosamide	Lacosamide 100 mg/1	TabletOral	AvPAK	50268-492	50268-0492-10
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4689	70518-4689-0070518-4689-0270518-4689-03
Lacosamide	Lacosamide 10 mg/mL	Injection, SolutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-697	68462-0697-30
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4562	70518-4562-00
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4561	70518-4561-0070518-4561-02
Lacosamide	Lacosamide 10 mg/mL	Injection, SolutionIntravenous	Anthea Pharma Private Limited	83854-002	83854-0002-10
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4503	70518-4503-00
Lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4504	70518-4504-0070518-4504-0170518-4504-03
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4505	70518-4505-00

All 147 Lacosamide NDCs

Other NDCs under ANDA 204921

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204921
Product	Strength	Form · route	Labeler	Product NDC
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-721
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-722
Lacosamide	Lacosamide 150 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-723
Lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-724
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	Breckenridge Pharmaceutical, Inc.	51991-348
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	Breckenridge Pharmaceutical, Inc.	51991-349
Lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	Breckenridge Pharmaceutical, Inc.	51991-351
lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	MSN LABORATORIES PRIVATE LIMITED	69539-025
lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	MSN LABORATORIES PRIVATE LIMITED	69539-026
lacosamide	Lacosamide 150 mg/1	Tablet, Film coatedOral	MSN LABORATORIES PRIVATE LIMITED	69539-027
lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	MSN LABORATORIES PRIVATE LIMITED	69539-028