What is NDC 43598-550?

43598-550 is the product NDC for Lamotrigine, Lamotrigine 25 mg/1 tablet, orally disintegrating, listed with the FDA by Dr. Reddys Laboratories Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddys Laboratories Inc., NDC labeler code 43598. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lamotrigine NDC 43598-550 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-550Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0550Add 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
43598-550-01	4359805500143598055001	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43598-550-01)Marketed from Jun 17, 2016
43598-550-30	4359805503043598055030	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43598-550-30)Marketed from Jun 17, 2016

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 — 25 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Dr. Reddys Laboratories Inc.NDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206382
Marketing start: Jun 17, 2016
Listing expires: Dec 31, 2027
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 43598-550_968e8167-da3e-4dbb-a21f-0f57de85d2c2SPL ID 968e8167-da3e-4dbb-a21f-0f57de85d2c2SPL set ID 54ea1ec3-876b-4d3a-a92b-1a6d70951de0RxCUI 103968, 198430, 252478, 252479UNII U3H27498KSUPC 0343598551302, 0343598550015, 0343598553306, 0343598550305, 0343598552309
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

N443598055001 followed by a unit qualifier and the quantity

Package 43598-0550-01. 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 Aug 5, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Lamotrigine 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: Treat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-550

What is NDC 43598-550?: 43598-550 is the product NDC for Lamotrigine, Lamotrigine 25 mg/1 tablet, orally disintegrating, listed with the FDA by Dr. Reddys Laboratories Inc.. It has 2 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?: Dr. Reddys Laboratories Inc., NDC labeler code 43598. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4702	70518-4702-00
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Coupler LLC	67046-0358	67046-0358-03
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Coupler LLC	67046-0749	67046-0749-03
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Coupler LLC	67046-0359	67046-0359-03
lamotriginelamotrigine extended-release	Lamotrigine 200 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4638	70518-4638-00
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-770	62332-0770-1562332-0770-30
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-771	62332-0771-1562332-0771-30
Lamotrigine	Lamotrigine 100 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-772	62332-0772-1062332-0772-30
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-773	62332-0773-1062332-0773-30
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Limited	46708-770	46708-0770-1546708-0770-30

All 263 Lamotrigine NDCs

Other NDCs under ANDA 206382

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

FDA NDC Directory listings under ANDA 206382
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Orally disintegratingOral	Dr. Reddys Laboratories Inc.	43598-551
Lamotrigine	Lamotrigine 100 mg/1	Tablet, Orally disintegratingOral	Dr. Reddys Laboratories Inc.	43598-552
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Orally disintegratingOral	Dr. Reddys Laboratories Inc.	43598-553
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Orally disintegratingOral	ScieGen Pharmaceuticals, Inc.	50228-319
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Orally disintegratingOral	ScieGen Pharmaceuticals, Inc.	50228-320
Lamotrigine	Lamotrigine 100 mg/1	Tablet, Orally disintegratingOral	ScieGen Pharmaceuticals, Inc.	50228-321
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Orally disintegratingOral	ScieGen Pharmaceuticals, Inc.	50228-322