NDC codes

FDA NDC Directory
Product NDC (as listed)16714-626Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0626Add 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
16714-626-01167140626011671406260130 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-626-01)Marketed from Jun 20, 2017

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, Extended release
Route
Oral
Labeler
NorthStar Rx LLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202383
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 16714-626_77f5183c-b6b1-c8e4-2757-8d318ea6cf9dSPL ID 77f5183c-b6b1-c8e4-2757-8d318ea6cf9dSPL set ID 9ab07d6b-ae4a-a310-5572-b266676cd29eRxCUI 850087, 850091, 900156, 900164, 1098608, 1146690UNII 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

N416714062601 followed by a unit qualifier and the quantity

Package 16714-0626-01. 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 extended-release tablets are indicated for: adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1) conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). (1.2) Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. (1.3) 1.1 Adjunctive Therapy Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or wi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-626

What is NDC 16714-626?
16714-626 is the product NDC for Lamotrigine, Lamotrigine 200 mg/1 tablet, extended release, listed with the FDA by NorthStar Rx LLC. 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?
NorthStar Rx LLC, NDC labeler code 16714. 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 202383

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

FDA NDC Directory listings under ANDA 202383
ProductStrengthForm · routeLabelerProduct NDC
LamotrigineLamotrigine 25 mg/1Tablet, Extended releaseOralNorthStar Rx LLC16714-623
LamotrigineLamotrigine 50 mg/1Tablet, Extended releaseOralNorthStar Rx LLC16714-624
LamotrigineLamotrigine 100 mg/1Tablet, Extended releaseOralNorthStar Rx LLC16714-625
LamotrigineLamotrigine 300 mg/1Tablet, Extended releaseOralNorthStar Rx LLC16714-627
LamotrigineLamotrigine 250 mg/1Tablet, Extended releaseOralNorthStar Rx LLC16714-893
LamotrigineLamotrigine 250 mg/1Tablet, Extended releaseOralDr.Reddy's Laboratories Limited55111-419
LamotrigineLamotrigine 300 mg/1Tablet, Extended releaseOralDr.Reddy's Laboratories Limited55111-428
LamotrigineLamotrigine 25 mg/1Tablet, Extended releaseOralDr.Reddy's Laboratories Limited55111-717
LamotrigineLamotrigine 50 mg/1Tablet, Extended releaseOralDr.Reddy's Laboratories Limited55111-718
LamotrigineLamotrigine 100 mg/1Tablet, Extended releaseOralDr.Reddy's Laboratories Limited55111-719
LamotrigineLamotrigine 200 mg/1Tablet, Extended releaseOralDr.Reddy's Laboratories Limited55111-720
LamotrigineLamotrigine 50 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4121

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