NDC codes

FDA NDC Directory
Product NDC (as listed)46708-276Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46708-0276Add 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
46708-276-304670802763030 TABLET in 1 BOTTLE (46708-276-30)Marketed from Jan 1, 2013
46708-276-3146708027631100 TABLET in 1 BOTTLE (46708-276-31)Marketed from Jan 1, 2013
46708-276-604670802766060 TABLET in 1 BOTTLE (46708-276-60)Marketed from Jan 1, 2013
46708-276-7146708027671500 TABLET in 1 BOTTLE (46708-276-71)Marketed from Jan 1, 2013
46708-276-91467080276911000 TABLET in 1 BOTTLE (46708-276-91)Marketed from Jan 1, 2013

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
Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090607
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 46708-276_c0f1f48a-19e7-4d18-a28e-c20531d83db7SPL ID c0f1f48a-19e7-4d18-a28e-c20531d83db7SPL set ID ccb33cd0-e5f7-4a50-8b55-ad7c432cdb77RxCUI 198427, 198428, 198429, 282401UNII U3H27498KSUPC 0346708277307, 0346708274306, 0346708275303
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

N446708027630 followed by a unit qualifier and the quantity

Package 46708-0276-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Lamotrigine 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 AED. (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: Trea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-276

What is NDC 46708-276?
46708-276 is the product NDC for Lamotrigine, Lamotrigine 150 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 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?
Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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
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 Limited46708-77046708-0770-1546708-0770-30
LamotrigineLamotrigine 50 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Limited46708-77146708-0771-1546708-0771-30
LamotrigineLamotrigine 100 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Limited46708-77246708-0772-1046708-0772-30
LamotrigineLamotrigine 200 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Limited46708-77346708-0773-1046708-0773-30
LamotrigineLamotrigine 25 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Inc.62332-77062332-0770-1562332-0770-30

All 260 Lamotrigine NDCs

Other NDCs under ANDA 090607

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

FDA NDC Directory listings under ANDA 090607
ProductStrengthForm · routeLabelerProduct NDC
LamotrigineLamotrigine 25 mg/1TabletOralAlembic Pharmaceuticals Limited46708-274
LamotrigineLamotrigine 100 mg/1TabletOralAlembic Pharmaceuticals Limited46708-275
LamotrigineLamotrigine 200 mg/1TabletOralAlembic Pharmaceuticals Limited46708-277
LamotrigineLamotrigine 25 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-037
LamotrigineLamotrigine 100 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-038
LamotrigineLamotrigine 150 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-039
LamotrigineLamotrigine 200 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-040

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