What is NDC 65162-988?

65162-988 is the product NDC for Lamotrigine, Lamotrigine 250 mg/1 tablet, film coated, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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?

261 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 65162-988 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-988Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0988Add 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
65162-988-03	65162098803	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-988-03)Marketed from Nov 30, 2018
65162-988-09	65162098809	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-988-09)Marketed from Nov 30, 2018

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 — 250 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207497
Marketing start: Nov 30, 2018
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 65162-988_cfe3f042-c606-4e0a-87d9-c306eab17230SPL ID cfe3f042-c606-4e0a-87d9-c306eab17230SPL set ID 0833d3df-2df1-4abd-abe0-7fb2c0253c80RxCUI 850087, 850091, 900156, 900164, 1098608, 1146690UNII U3H27498KSUPC 0365162958034, 0365162986037, 0365162949032, 0365162990034, 0365162956030
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

N465162098803 followed by a unit qualifier and the quantity

Package 65162-0988-03. 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 Aug 13, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Lamotrigine extended-release tablets are indicated for: adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1) conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). (1.2) Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. (1.3) 1.1 Adjunctive Therapy Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or wi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-988

What is NDC 65162-988?: 65162-988 is the product NDC for Lamotrigine, Lamotrigine 250 mg/1 tablet, film coated, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 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?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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?: 261 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 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 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 Limited	46708-773	46708-0773-1046708-0773-30

All 262 Lamotrigine NDCs

Other NDCs under ANDA 207497

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

FDA NDC Directory listings under ANDA 207497
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 100 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-445
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-443
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-444
Lamotrigine	Lamotrigine 300 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-448
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-446
Lamotrigine	Lamotrigine 250 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-447
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Film coated, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-986
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Film coated, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-949
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Film coated, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-956
Lamotrigine	Lamotrigine 100 mg/1	Tablet, Film coated, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-958
Lamotrigine	Lamotrigine 300 mg/1	Tablet, Film coated, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-990