What is NDC 68382-109?

68382-109 is the product NDC for Lamotrigine, Lamotrigine 25 mg/1 tablet, chewable, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 68382-109 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-109Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0109Add 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
68382-109-01	68382010901	100 TABLET, CHEWABLE in 1 BOTTLE (68382-109-01)Marketed from Jan 23, 2009
68382-109-05	68382010905	500 TABLET, CHEWABLE in 1 BOTTLE (68382-109-05)Marketed from Jan 23, 2009
68382-109-16	68382010916	90 TABLET, CHEWABLE in 1 BOTTLE (68382-109-16)Marketed from Jan 23, 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, Chewable
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078009
Marketing start: Jan 23, 2009
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 68382-109_277200d5-a863-4411-8c1b-aac8d7fde6a6SPL ID 277200d5-a863-4411-8c1b-aac8d7fde6a6SPL set ID e849033b-a3bc-408e-88de-7cd1d2660949RxCUI 198427, 198428, 198429, 199322, 249329, 282401, 311264, 311265UNII U3H27498KSUPC 0368382109019, 0368382011053, 0368382108012
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

N468382010901 followed by a unit qualifier and the quantity

Package 68382-0109-01. 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 Nov 14, 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 (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 Treatm…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-109

What is NDC 68382-109?: 68382-109 is the product NDC for Lamotrigine, Lamotrigine 25 mg/1 tablet, chewable, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 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 Pharmaceuticals USA Inc., NDC labeler code 68382. 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 100 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Limited	46708-772	46708-0772-1046708-0772-30
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Limited	46708-770	46708-0770-1546708-0770-30
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Limited	46708-771	46708-0771-1546708-0771-30
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 078009

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

FDA NDC Directory listings under ANDA 078009
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 5 mg/1	Tablet, ChewableOral	Zydus Lifesciences Limited	65841-689
Lamotrigine	Lamotrigine 25 mg/1	Tablet, ChewableOral	Zydus Lifesciences Limited	65841-690
Lamotrigine	Lamotrigine 5 mg/1	Tablet, ChewableOral	Zydus Pharmaceuticals USA Inc.	68382-108