NDC codes

FDA NDC Directory
Product NDC (as listed)65841-685Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65841-0685Add 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
65841-685-056584106850565841068505500 TABLET in 1 BOTTLE (65841-685-05)Marketed from Jan 27, 2009
65841-685-14658410685146584106851460 TABLET in 1 BOTTLE (65841-685-14)Marketed from Jan 27, 2009
65841-685-16658410685166584106851690 TABLET in 1 BOTTLE (65841-685-16)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 — 150 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Zydus Lifesciences LimitedNDC labeler code 65841
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 65841-685_c4eb074b-9cd4-4bcd-868c-473d9364061cSPL ID c4eb074b-9cd4-4bcd-868c-473d9364061cSPL set ID 0f2f7421-56d4-45d0-9d2d-dc1edaede039RxCUI 198427, 198428, 198429, 199322, 249329, 282401, 311264, 311265UNII U3H27498KSUPC 0365841687057
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

N465841068505 followed by a unit qualifier and the quantity

Package 65841-0685-05. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 65841-685

What is NDC 65841-685?
65841-685 is the product NDC for Lamotrigine, Lamotrigine 150 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. 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?
Zydus Lifesciences Limited, NDC labeler code 65841. 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

Showing 20 of 39.

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