What is NDC 80425-0289?

80425-0289 is the product NDC for Lamotrigine, Lamotrigine 25 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 80425-0289 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0289Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0289Add 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
80425-0289-1	8042502890180425028901	30 TABLET in 1 BOTTLE (80425-0289-1)Marketed from Mar 24, 2023
80425-0289-2	8042502890280425028902	60 TABLET in 1 BOTTLE (80425-0289-2)Marketed from Mar 24, 2023
80425-0289-3	8042502890380425028903	90 TABLET in 1 BOTTLE (80425-0289-3)Marketed from Mar 24, 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 — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090170
Marketing start: Mar 24, 2023
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 80425-0289_2a9b9724-0258-e829-e063-6394a90a1c07SPL ID 2a9b9724-0258-e829-e063-6394a90a1c07SPL set ID f7a86237-ece4-7cc4-e053-6294a90a1308RxCUI 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

N480425028901 followed by a unit qualifier and the quantity

Package 80425-0289-01. 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 Dec 31, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

1. Indications and Usage 1.1 Epilepsy Adjunctive Therapy Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. Monotherapy Lamotrigine tablets are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine tablets have not been established (1) as initial monotherapy; (2) for conversi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0289

What is NDC 80425-0289?: 80425-0289 is the product NDC for Lamotrigine, Lamotrigine 25 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. 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?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 090170

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

FDA NDC Directory listings under ANDA 090170
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	A-S Medication Solutions	50090-3914
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	REMEDYREPACK INC.	70518-1479
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Northwind Health Company, LLC	51655-719
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	REMEDYREPACK INC.	70518-2577
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Bryant Ranch Prepack	71335-1110
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Proficient Rx LP	63187-487
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-113
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-114
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Bryant Ranch Prepack	71335-1179
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-0706
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Proficient Rx LP	71205-245
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-1908
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	REMEDYREPACK INC.	70518-1978
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-0830
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	Asclemed USA, Inc.	76420-182
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-111
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-112
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-206
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Coupler LLC	67046-0358
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	A-S Medication Solutions	50090-2130

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