What is NDC 72189-560?

72189-560 is the product NDC for Lamotrigine ER, Lamotrigine 200 mg/1 tablet, film coated, extended release, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_rx, NDC labeler code 72189. 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 ER?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lamotrigine ER NDC 72189-560 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-560Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0560Add 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 NDC	11-digit (billing)	Package	Copy
72189-560-30	7218905603072189056030	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-560-30)Marketed from Jun 19, 2024

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 ER
Generic name (nonproprietary): lamotrigine er
Active ingredients: Lamotrigine — 200 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Direct_rxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213949
Marketing start: Jun 19, 2024
Listing expires: Dec 31, 2026
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 72189-560_1b42a7cf-86d9-e506-e063-6394a90a3c9bSPL ID 1b42a7cf-86d9-e506-e063-6394a90a3c9bSPL set ID 1b42a7cf-86d8-e506-e063-6394a90a3c9bRxCUI 900156UNII 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

N472189056030 followed by a unit qualifier and the quantity

Package 72189-0560-30. 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 Jun 19, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

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 without secondary generalization in patients aged 13 years and older. 1.2 Monotherapy Lamotrigine Extended-Release Tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Safety and effectiveness of Lamotrigine Extended-Release Tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.3 Limitation o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-560

What is NDC 72189-560?: 72189-560 is the product NDC for Lamotrigine ER, Lamotrigine 200 mg/1 tablet, film coated, extended release, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lamotrigine ER.
What is the active ingredient?: Lamotrigine.
Who is the labeler?: Direct_rx, NDC labeler code 72189. 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 ER?: 1 other product NDC are listed under this name. See all Lamotrigine ER 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 ER NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lamotrigine ER	Lamotrigine 200 mg/1	Tablet, Extended releaseOral	Direct_Rx	72189-467	72189-0467-30

Other NDCs under ANDA 213949

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

FDA NDC Directory listings under ANDA 213949
Product	Strength	Form · route	Labeler	Product NDC
lamotriginelamotrigine extended-release	Lamotrigine 200 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4638
lamotriginelamotrigine extended-release	Lamotrigine 50 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4442
lamotriginelamotrigine extended-release	Lamotrigine 50 mg/1	Tablet, Film coated, Extended releaseOral	Proficient Rx LP	82804-022
lamotriginelamotrigine extended-release	Lamotrigine 200 mg/1	Tablet, Film coated, Extended releaseOral	Yiling Pharmaceutical, Inc.	69117-0047
lamotriginelamotrigine extended-release	Lamotrigine 25 mg/1	Tablet, Film coated, Extended releaseOral	Yiling Pharmaceutical, Inc.	69117-0044
lamotriginelamotrigine extended-release	Lamotrigine 50 mg/1	Tablet, Film coated, Extended releaseOral	Yiling Pharmaceutical, Inc.	69117-0045
lamotriginelamotrigine extended-release	Lamotrigine 100 mg/1	Tablet, Film coated, Extended releaseOral	Yiling Pharmaceutical, Inc.	69117-0046
lamotriginelamotrigine extended-release	Lamotrigine 250 mg/1	Tablet, Film coated, Extended releaseOral	Yiling Pharmaceutical, Inc.	69117-0048
lamotriginelamotrigine extended-release	Lamotrigine 300 mg/1	Tablet, Film coated, Extended releaseOral	Yiling Pharmaceutical, Inc.	69117-0049
lamotriginelamotrigine extended-release	Lamotrigine 50 mg/1	Tablet, Film coated, Extended releaseOral	Camber Pharmaceuticals Inc	31722-241
lamotriginelamotrigine extended-release	Lamotrigine 25 mg/1	Tablet, Film coated, Extended releaseOral	Camber Pharmaceuticals Inc	31722-240
lamotriginelamotrigine extended-release	Lamotrigine 300 mg/1	Tablet, Film coated, Extended releaseOral	Camber Pharmaceuticals Inc	31722-245
lamotriginelamotrigine extended-release	Lamotrigine 100 mg/1	Tablet, Film coated, Extended releaseOral	Camber Pharmaceuticals Inc	31722-242
lamotriginelamotrigine extended-release	Lamotrigine 200 mg/1	Tablet, Film coated, Extended releaseOral	Camber Pharmaceuticals Inc	31722-243
lamotriginelamotrigine extended-release	Lamotrigine 250 mg/1	Tablet, Film coated, Extended releaseOral	Camber Pharmaceuticals Inc	31722-244