What is NDC 82804-068?

82804-068 is the product NDC for Lamotrigine, Lamotrigine 200 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 82804. 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?

259 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 82804-068 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-068Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0068Add 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
82804-068-30	82804006830	30 TABLET in 1 BOTTLE, PLASTIC (82804-068-30)Marketed from Jan 31, 2024
82804-068-60	82804006860	60 TABLET in 1 BOTTLE, PLASTIC (82804-068-60)Marketed from Jan 31, 2024
82804-068-90	82804006890	90 TABLET in 1 BOTTLE, PLASTIC (82804-068-90)Marketed from Jan 31, 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 — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 82804
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090170
Marketing start: Nov 1, 2011
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 82804-068_6f7e59d2-4311-42a0-93a0-b29b0417d96fSPL ID 6f7e59d2-4311-42a0-93a0-b29b0417d96fSPL set ID 6f7e59d2-4311-42a0-93a0-b29b0417d96fRxCUI 198429UNII U3H27498KSUPC 0382804068302
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

N482804006830 followed by a unit qualifier and the quantity

Package 82804-0068-30. 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 Feb 1, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Lamotrigine tablets are 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82804-068

What is NDC 82804-068?: 82804-068 is the product NDC for Lamotrigine, Lamotrigine 200 mg/1 tablet, listed with the FDA by Proficient Rx LP. 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?: Proficient Rx LP, NDC labeler code 82804. 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?: 259 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 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 100 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Limited	46708-772	46708-0772-1046708-0772-30
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Limited	46708-773	46708-0773-1046708-0773-30
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-770	62332-0770-1562332-0770-30

All 260 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 25 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-111
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-112
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	A-S Medication Solutions	50090-2129
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	A-S Medication Solutions	50090-2130
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	A-S Medication Solutions	50090-2131
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	A-S Medication Solutions	50090-3914
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Northwind Health Company, LLC	51655-719
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Proficient Rx LP	63187-487
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Coupler LLC	67046-0358
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Coupler LLC	67046-0359
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Coupler LLC	67046-0749
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7223
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Preferred Pharmaceuticals, Inc.	68788-7544
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	REMEDYREPACK INC.	70518-1479
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-1908
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	REMEDYREPACK INC.	70518-1978
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-2343
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	REMEDYREPACK INC.	70518-2406

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