What is NDC 0115-1527?

0115-1527 is the product NDC for Lamotrigine, Lamotrigine 50 mg/1 tablet, orally disintegrating, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 0115-1527 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-1527Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-1527Add 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
0115-1527-08	0011515270800115152708	2 BLISTER PACK in 1 CARTON (0115-1527-08) / 15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1527-68)Marketed from Jan 9, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 50 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200828
Marketing start: Jan 9, 2015
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 0115-1527_9611e358-6fe1-4f8d-99a2-250a7862a896SPL ID 9611e358-6fe1-4f8d-99a2-250a7862a896SPL set ID 380bddae-5b31-4965-96de-97711d859d11RxCUI 103968, 198430, 252478, 252479UNII 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

N400115152708 followed by a unit qualifier and the quantity

Package 00115-1527-08. 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 Feb 2, 2016. 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 AED. ( 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 of acute manic o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0115-1527

What is NDC 0115-1527?: 0115-1527 is the product NDC for Lamotrigine, Lamotrigine 50 mg/1 tablet, orally disintegrating, listed with the FDA by Amneal Pharmaceuticals of New York LLC. 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?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 200828

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

FDA NDC Directory listings under ANDA 200828
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Orally disintegratingOral	Amneal Pharmaceuticals of New York LLC	0115-9940
Lamotrigine	Lamotrigine 100 mg/1	Tablet, Orally disintegratingOral	Amneal Pharmaceuticals of New York LLC	0115-9941
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Orally disintegratingOral	Amneal Pharmaceuticals of New York LLC	0115-9942
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Orally disintegratingOral	Amneal Pharmaceuticals of New York LLC	0115-9939
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Orally disintegratingOral	Amneal Pharmaceuticals of New York LLC	0115-1526
Lamotrigine	Lamotrigine 100 mg/1	Tablet, Orally disintegratingOral	Amneal Pharmaceuticals of New York LLC	0115-1528
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Orally disintegratingOral	Amneal Pharmaceuticals of New York LLC	0115-1529