What is NDC 82804-991?

82804-991 is the product NDC for Lacosamide, Lacosamide 100 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 9 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 82804. 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 82804-991 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-991Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0991Add 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
82804-991-00	8280409910082804099100	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-00)Marketed from May 21, 2024
82804-991-11	8280409911182804099111	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-11)Marketed from May 21, 2024
82804-991-30	8280409913082804099130	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-30)Marketed from May 21, 2024
82804-991-55	8280409915582804099155	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-55)Marketed from May 21, 2024
82804-991-60	8280409916082804099160	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-60)Marketed from May 21, 2024
82804-991-64	8280409916482804099164	240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-64)Marketed from May 21, 2024
82804-991-72	8280409917282804099172	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-72)Marketed from May 21, 2024
82804-991-78	8280409917882804099178	180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-78)Marketed from May 21, 2024
82804-991-90	8280409919082804099190	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-90)Marketed from May 21, 2024

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 — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 82804
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205237
Marketing start: Jul 10, 2023
Listing expires: Dec 31, 2027
DEA schedule: CV
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 82804-991_47ae2f1f-d135-4f4e-acc2-500c1afa7b8bSPL ID 47ae2f1f-d135-4f4e-acc2-500c1afa7b8bSPL set ID 47ae2f1f-d135-4f4e-acc2-500c1afa7b8bRxCUI 809987, 809992, 809996, 810000UNII 563KS2PQY5UPC 0382804993307, 0382804991303, 0382804990306, 0382804992300

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

N482804099100 followed by a unit qualifier and the quantity

Package 82804-0991-00. 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 May 1, 2024.

Indications (excerpt from the label)

Lacosamide is indicated for: • Treatment of partial-onset seizures in patients 4 years of age and older ( 1.1 ) 1.1 Partial-Onset Seizures Lacosamide is 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 pediatric information.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82804-991

What is NDC 82804-991?: 82804-991 is the product NDC for Lacosamide, Lacosamide 100 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 9 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?: Proficient Rx LP, NDC labeler code 82804. 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 205237

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

FDA NDC Directory listings under ANDA 205237
Product	Strength	Form · route	Labeler	Product NDC
Lacosamide	Lacosamide 150 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-350
Lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-351
Lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals Inc	50228-195
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals Inc	50228-192
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals Inc	50228-193
Lacosamide	Lacosamide 150 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals Inc	50228-194
Lacosamide	Lacosamide 150 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-992
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-990
Lacosamide	Lacosamide 200 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-993
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4562
Lacosamide	Lacosamide 100 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-349
Lacosamide	Lacosamide 50 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-348