What is NDC 68071-3607?

68071-3607 is the product NDC for Lamotrigine, Lamotrigine 100 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 68071-3607 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3607Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3607Add 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
68071-3607-6	6807136070668071360706	60 TABLET in 1 BOTTLE (68071-3607-6)Marketed from Jun 25, 2024

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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078947
Marketing start: Jan 27, 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 68071-3607_1bbbeda6-9835-6c1c-e063-6294a90ad1abSPL ID 1bbbeda6-9835-6c1c-e063-6294a90ad1abSPL set ID 1bbbe2a2-a9e8-8c13-e063-6394a90a9627RxCUI 198427UNII U3H27498KSUPC 0368071360769
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

N468071360706 followed by a unit qualifier and the quantity

Package 68071-3607-06. 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 Jun 25, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Lamotrigine, USP 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 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: Treatme…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-3607

What is NDC 68071-3607?: 68071-3607 is the product NDC for Lamotrigine, Lamotrigine 100 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. 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?: NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 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	Torrent Pharmaceuticals Limited	13668-045
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-047
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-048
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-049
Lamotrigine	—	Kit	Torrent Pharmaceuticals Limited	13668-266
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-203
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-238
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	A-S Medication Solutions	50090-6028
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Northwind Health Company, LLC	51655-855
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	OWP Pharmaceuticals, Inc.	69102-639
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-2755
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-2889
LAMOTRIGINE Kitlamotrigine	—	Kit	OWP Pharmaceuticals, Inc.	69102-137
LAMOTRIGINE Kitlamotrigine	—	Kit	OWP Pharmaceuticals, Inc.	69102-359
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
Subvenitelamotrigine	—	Kit	OWP Pharmaceuticals, Inc.	69102-306
Subvenitelamotrigine	—	Kit	OWP Pharmaceuticals, Inc.	69102-312
Subvenitelamotrigine	Lamotrigine 100 mg/1	TabletOral	OWP Pharmaceuticals, Inc.	69102-319

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