What is NDC 46708-419?

46708-419 is the product NDC for Lamotrigine, Lamotrigine 300 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-419 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-419Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0419Add 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
46708-419-30	46708041930	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-419-30)Marketed from Oct 7, 2024
46708-419-91	46708041991	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-419-91)Marketed from Oct 7, 2024

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 — 300 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211821
Marketing start: Oct 7, 2024
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 46708-419_faee013c-cad2-4abb-904c-e6ff79ba778cSPL ID faee013c-cad2-4abb-904c-e6ff79ba778cSPL set ID faee013c-cad2-4abb-904c-e6ff79ba778cRxCUI 900156, 1098608, 1146690UNII U3H27498KSUPC 0346708417307, 0346708419301, 0346708418304
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

N446708041930 followed by a unit qualifier and the quantity

Package 46708-0419-30. 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 Oct 11, 2024. 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 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. (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 without seconda…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-419

What is NDC 46708-419?: 46708-419 is the product NDC for Lamotrigine, Lamotrigine 300 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 211821

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

FDA NDC Directory listings under ANDA 211821
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 250 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-418
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-417
Lamotrigine	Lamotrigine 250 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-418
Lamotrigine	Lamotrigine 300 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-419
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-417