NDC codes

FDA NDC Directory
Product NDC (as listed)68788-7871Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7871Add 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 NDC11-digit (billing)PackageCopy
68788-7871-3687887871036878878710330 TABLET in 1 BOTTLE (68788-7871-3)Marketed from Feb 15, 2021
68788-7871-6687887871066878878710660 TABLET in 1 BOTTLE (68788-7871-6)Marketed from Feb 15, 2021
68788-7871-9687887871096878878710990 TABLET in 1 BOTTLE (68788-7871-9)Marketed from Feb 15, 2021

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
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077633
Marketing start
Listing expires
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 68788-7871_2a1f59e0-2c69-4fa9-ab8a-1f7a2163aad7SPL ID 2a1f59e0-2c69-4fa9-ab8a-1f7a2163aad7SPL set ID 634dbe6c-4874-4d54-aa25-be02d3341f16RxCUI 198427UNII 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

N468788787103 followed by a unit qualifier and the quantity

Package 68788-7871-03. 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 . 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 (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)

About NDC 68788-7871

What is NDC 68788-7871?
68788-7871 is the product NDC for Lamotrigine, Lamotrigine 100 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LamotrigineLamotrigine 50 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-470270518-4702-00
LamotrigineLamotrigine 25 mg/1TabletOralCoupler LLC67046-035867046-0358-03
LamotrigineLamotrigine 150 mg/1TabletOralCoupler LLC67046-074967046-0749-03
LamotrigineLamotrigine 100 mg/1TabletOralCoupler LLC67046-035967046-0359-03
lamotriginelamotrigine extended-releaseLamotrigine 200 mg/1Tablet, Film coated, Extended releaseOralREMEDYREPACK INC.70518-463870518-4638-00
LamotrigineLamotrigine 25 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Inc.62332-77062332-0770-1562332-0770-30
LamotrigineLamotrigine 50 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Inc.62332-77162332-0771-1562332-0771-30
LamotrigineLamotrigine 100 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Inc.62332-77262332-0772-1062332-0772-30
LamotrigineLamotrigine 200 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Inc.62332-77362332-0773-1062332-0773-30
LamotrigineLamotrigine 25 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Limited46708-77046708-0770-1546708-0770-30

All 263 Lamotrigine NDCs

Other NDCs under ANDA 077633

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

FDA NDC Directory listings under ANDA 077633
ProductStrengthForm · routeLabelerProduct NDC
LamotrigineLamotrigine 150 mg/1TabletOralAmerican Health Packaging60687-693
LamotrigineLamotrigine 200 mg/1TabletOralAmerican Health Packaging60687-704
LamotrigineLamotrigine 25 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-006
LamotrigineLamotrigine 50 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-007
LamotrigineLamotrigine 100 mg/1TabletOralREMEDYREPACK INC.70518-2563
LamotrigineLamotrigine 100 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-008
LamotrigineLamotrigine 150 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-009
LamotrigineLamotrigine 200 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-010
LamotrigineLamotrigine 250 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-011
LamotrigineLamotrigine 150 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-133
LamotrigineLamotrigine 25 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-131
LamotrigineLamotrigine 100 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-132
LamotrigineLamotrigine 200 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-134
LamotrigineLamotrigine 100 mg/1TabletOralNorthwind Health Company, LLC82868-005
LamotrigineLamotrigine 200 mg/1TabletOralBryant Ranch Prepack71335-1919
LamotrigineLamotrigine 100 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3514
LamotrigineLamotrigine 100 mg/1TabletOralCardinal Health 107, LLC55154-2065
LamotrigineLamotrigine 100 mg/1TabletOralA-S Medication Solutions50090-5827
LamotrigineLamotrigine 150 mg/1TabletOralA-S Medication Solutions50090-5850
LamotrigineLamotrigine 200 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8267

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