What is NDC 68084-318?

68084-318 is the product NDC for Lamotrigine, Lamotrigine 25 mg/1 tablet, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.

American Health Packaging, NDC labeler code 68084. 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 68084-318 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68084-318Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68084-0318Add 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
68084-318-01	6808403180168084031801	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-318-01) / 1 TABLET in 1 BLISTER PACK (68084-318-11)Marketed from Jul 7, 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 — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: American Health PackagingNDC labeler code 68084
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077633
Marketing start: Jul 7, 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 68084-318_57d4fcd2-5f9e-1832-e063-6394a90a63f2SPL ID 57d4fcd2-5f9e-1832-e063-6394a90a63f2SPL set ID 35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234RxCUI 198427, 282401UNII U3H27498KS
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

N468084031801 followed by a unit qualifier and the quantity

Package 68084-0318-01. 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 Jul 30, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Lamotrigine is indicated for: Epilepsy — adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. (1.1) Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1) Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68084-318

What is NDC 68084-318?: 68084-318 is the product NDC for Lamotrigine, Lamotrigine 25 mg/1 tablet, listed with the FDA by American Health Packaging. It has 1 package NDC, 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?: American Health Packaging, NDC labeler code 68084. 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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