What is NDC 68071-3514?

68071-3514 is the product NDC for Lamotrigine, Lamotrigine 100 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 68071-3514 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3514Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3514Add 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
68071-3514-6	68071351406	60 TABLET in 1 BOTTLE (68071-3514-6)Marketed from Sep 27, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077633
Marketing start: Nov 17, 2021
Listing expires: Dec 31, 2026
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 68071-3514_2d04df29-9c20-be48-e063-6294a90a16d1SPL ID 2d04df29-9c20-be48-e063-6294a90a16d1SPL set ID 065e97c9-3c5f-16e6-e063-6294a90a13fcRxCUI 198427UNII U3H27498KSUPC 0368071351460
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

N468071351406 followed by a unit qualifier and the quantity

Package 68071-3514-06. 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 Jan 31, 2025. 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 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 68071-3514

What is NDC 68071-3514?: 68071-3514 is the product NDC for Lamotrigine, Lamotrigine 100 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. 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?: NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 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 200 mg/1	TabletOral	Northstar Rx LLC.	16714-197
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Northstar Rx LLC.	16714-194
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Northstar Rx LLC.	16714-195
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Northstar Rx LLC.	16714-196
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-008
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 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 25 mg/1	TabletOral	Major Pharmaceuticals	0904-7007
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-2563
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	American Health Packaging	60687-693
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Major Pharmaceuticals	0904-7008
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	American Health Packaging	60687-704
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2065
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8267
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7964
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2330
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2331

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