Lamotrigine NDC 13668-049

NDC codes

FDA NDC Directory

Product NDC (as listed)13668-049Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13668-0049Add 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
13668-049-01	13668004901	100 TABLET in 1 BOTTLE (13668-049-01)Marketed from Jan 27, 2009
13668-049-05	13668004905	500 TABLET in 1 BOTTLE (13668-049-05)Marketed from Jan 27, 2009
13668-049-13	13668004913	1300 TABLET in 1 BOTTLE (13668-049-13)Marketed from Jan 27, 2009
13668-049-30	13668004930	30 TABLET in 1 BOTTLE (13668-049-30)Marketed from Jan 27, 2009
13668-049-60	13668004960	60 TABLET in 1 BOTTLE (13668-049-60)Marketed from Jan 27, 2009
13668-049-64	13668004964	90 TABLET in 1 DOSE PACK (13668-049-64)Marketed from Jan 27, 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 — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Torrent Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078947
Marketing start: Jan 27, 2009
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 13668-049_7f173ac5-3a79-4426-ae9b-7149427975abSPL ID 7f173ac5-3a79-4426-ae9b-7149427975abSPL set ID 3448839b-4933-4ef9-a80a-9e504d2c5696RxCUI 198427, 198428, 198429, 282401, 751139, 751563, 753451UNII U3H27498KSUPC 0313668048605, 0313668045017
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

N413668004901 followed by a unit qualifier and the quantity

Package 13668-0049-01. 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 Jul 16, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Lamotrigine tablet 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078947

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

FDA NDC Directory listings under ANDA 078947
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-2755
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Northwind Health Company, LLC	51655-855
LAMOTRIGINE Kitlamotrigine	—	Kit	OWP Pharmaceuticals, Inc.	69102-137
Subvenitelamotrigine	—	Kit	OWP Pharmaceuticals, Inc.	69102-306
Subvenitelamotrigine	Lamotrigine 150 mg/1	TabletOral	OWP Pharmaceuticals, Inc.	69102-150
Subvenitelamotrigine	—	Kit	OWP Pharmaceuticals, Inc.	69102-300
Subvenitelamotrigine	Lamotrigine 25 mg/1	TabletOral	OWP Pharmaceuticals, Inc.	69102-301
LAMOTRIGINE Kitlamotrigine	—	Kit	OWP Pharmaceuticals, Inc.	69102-359
Subvenitelamotrigine	—	Kit	OWP Pharmaceuticals, Inc.	69102-312
Subvenitelamotrigine	Lamotrigine 100 mg/1	TabletOral	OWP Pharmaceuticals, Inc.	69102-319
Subvenitelamotrigine	Lamotrigine 200 mg/1	TabletOral	OWP Pharmaceuticals, Inc.	69102-320
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-048
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-045
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-047
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	OWP Pharmaceuticals, Inc.	69102-639
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-2889
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3607
Lamotrigine	—	Kit	Torrent Pharmaceuticals Limited	13668-266
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	A-S Medication Solutions	50090-6028
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-238

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