Prescription drug · NDA

Lamictal (Lamotrigine) NDC 0173-0594

Kit · GlaxoSmithKline LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)0173-0594Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00173-0594Add 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
0173-0594-02001730594021 BLISTER PACK in 1 PACKAGE, COMBINATION (0173-0594-02) / 1 KIT in 1 BLISTER PACKMarketed from Sep 29, 2003

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Lamictal
Generic name (nonproprietary)
lamotrigine
Dosage form
Kit
Labeler
GlaxoSmithKline LLCNDC labeler code 0173
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020241
Marketing start
Listing expires
Identifiers
Product ID 0173-0594_076c76e0-4a5e-491b-ba85-de2dd757b436SPL ID 076c76e0-4a5e-491b-ba85-de2dd757b436SPL set ID d7e3572d-56fe-4727-2bb4-013ccca22678RxCUI 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, 206201, 252478, 252479, 282401, 311264, 311265, 349010, 542426, 751139, 751563, 753451, 795772, 795774, 795778, 849049, 849050, 849051, 849052, 851748, 851749, 851750, 851751, 851752, 851753UNII U3H27498KSUPC 0301730526007, 0301730644602, 0301730699008, 0301730642554, 0301730643605, 0301730527004

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400173059402 followed by a unit qualifier and the quantity

Package 00173-0594-02. 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)

LAMICTAL 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: Tr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0173-0594

What is NDC 0173-0594?
0173-0594 is the product NDC for Lamictal (lamotrigine) kit, listed with the FDA by GlaxoSmithKline LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Lamictal (Lamotrigine).
Who is the labeler?
GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lamictal?
8 other product NDCs are listed under this name. See all Lamictal 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 Lamictal NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Lamictallamotrigine—KitGlaxoSmithKline LLC0173-081700173-0817-28
LamictallamotrigineLamotrigine 2 mg/1Tablet, For suspensionOralGlaxoSmithKline LLC0173-069900173-0699-0000173-0699-02
LamictallamotrigineLamotrigine 5 mg/1Tablet, For suspensionOralGlaxoSmithKline LLC0173-052600173-0526-00
LamictallamotrigineLamotrigine 25 mg/1Tablet, For suspensionOralGlaxoSmithKline LLC0173-052700173-0527-00
LamictallamotrigineLamotrigine 25 mg/1TabletOralGlaxoSmithKline LLC0173-063300173-0633-0200173-0633-10
LamictallamotrigineLamotrigine 200 mg/1TabletOralGlaxoSmithKline LLC0173-064400173-0644-60
LamictallamotrigineLamotrigine 100 mg/1TabletOralGlaxoSmithKline LLC0173-064200173-0642-55
LamictallamotrigineLamotrigine 150 mg/1TabletOralGlaxoSmithKline LLC0173-064300173-0643-60

Other NDCs under NDA 020241

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

FDA NDC Directory listings under NDA 020241
ProductStrengthForm · routeLabelerProduct NDC
LamictallamotrigineLamotrigine 25 mg/1TabletOralGlaxoSmithKline LLC0173-0633
LamictallamotrigineLamotrigine 100 mg/1TabletOralGlaxoSmithKline LLC0173-0642
LamictallamotrigineLamotrigine 150 mg/1TabletOralGlaxoSmithKline LLC0173-0643
LamictallamotrigineLamotrigine 200 mg/1TabletOralGlaxoSmithKline LLC0173-0644
Lamictallamotrigine—KitGlaxoSmithKline LLC0173-0817

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Lamictal NDC 0173-0594 | National Drug Code | Med-Code