What is NDC 65841-684?

65841-684 is the product NDC for Lamotrigine, Lamotrigine 100 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 65841. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lamotrigine?

262 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lamotrigine NDC 65841-684 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65841-684Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65841-0684Add 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
65841-684-01	6584106840165841068401	100 TABLET in 1 BOTTLE (65841-684-01)Marketed from Jan 27, 2009
65841-684-05	6584106840565841068405	500 TABLET in 1 BOTTLE (65841-684-05)Marketed from Jan 27, 2009
65841-684-10	6584106841065841068410	1000 TABLET in 1 BOTTLE (65841-684-10)Marketed from Jan 27, 2009
65841-684-16	6584106841665841068416	90 TABLET in 1 BOTTLE (65841-684-16)Marketed from Jan 27, 2009

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): Lamotrigine
Generic name (nonproprietary): lamotrigine
Active ingredients: Lamotrigine — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 65841
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077633
Marketing start: Jan 27, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 65841-684_c4eb074b-9cd4-4bcd-868c-473d9364061cSPL ID c4eb074b-9cd4-4bcd-868c-473d9364061cSPL set ID 0f2f7421-56d4-45d0-9d2d-dc1edaede039RxCUI 198427, 198428, 198429, 199322, 249329, 282401, 311264, 311265UNII U3H27498KSUPC 0365841687057
Pharmacologic class: Anti-epileptic Agent; Mood Stabilizer

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

N465841068401 followed by a unit qualifier and the quantity

Package 65841-0684-01. 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 Oct 4, 2025.

Full label on DailyMed (opens in a new tab)

About NDC 65841-684

What is NDC 65841-684?: 65841-684 is the product NDC for Lamotrigine, Lamotrigine 100 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lamotrigine.
What is the active ingredient?: Lamotrigine.
Who is the labeler?: Zydus Lifesciences Limited, NDC labeler code 65841. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lamotrigine?: 262 other product NDCs are listed under this name. See all Lamotrigine 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 Lamotrigine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4702	70518-4702-00
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Coupler LLC	67046-0358	67046-0358-03
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Coupler LLC	67046-0749	67046-0749-03
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Coupler LLC	67046-0359	67046-0359-03
lamotriginelamotrigine extended-release	Lamotrigine 200 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4638	70518-4638-00
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-770	62332-0770-1562332-0770-30
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-771	62332-0771-1562332-0771-30
Lamotrigine	Lamotrigine 100 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-772	62332-0772-1062332-0772-30
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-773	62332-0773-1062332-0773-30
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Limited	46708-770	46708-0770-1546708-0770-30

All 263 Lamotrigine NDCs

Other NDCs under ANDA 077633

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

FDA NDC Directory listings under ANDA 077633
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	American Health Packaging	60687-693
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	American Health Packaging	60687-704
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-006
Lamotrigine	Lamotrigine 50 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-007
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-2563
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-008
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-009
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-010
Lamotrigine	Lamotrigine 250 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-011
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-133
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-131
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-132
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-134
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Northwind Health Company, LLC	82868-005
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-1919
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3514
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2065
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	A-S Medication Solutions	50090-5827
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	A-S Medication Solutions	50090-5850
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8267

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