NDC codes

FDA NDC Directory
Product NDC (as listed)43598-551Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0551Add 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
43598-551-30435980551304359805513030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43598-551-30)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 — 50 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
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 43598-551_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

N443598055130 followed by a unit qualifier and the quantity

Package 43598-0551-30. 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)

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 43598-551

What is NDC 43598-551?
43598-551 is the product NDC for Lamotrigine, Lamotrigine 50 mg/1 tablet, orally disintegrating, listed with the FDA by Dr. Reddys Laboratories Inc.. 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?
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
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 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
ProductStrengthForm · routeLabelerProduct NDC
LamotrigineLamotrigine 25 mg/1Tablet, Orally disintegratingOralDr. Reddys Laboratories Inc.43598-550
LamotrigineLamotrigine 100 mg/1Tablet, Orally disintegratingOralDr. Reddys Laboratories Inc.43598-552
LamotrigineLamotrigine 200 mg/1Tablet, Orally disintegratingOralDr. Reddys Laboratories Inc.43598-553
LamotrigineLamotrigine 25 mg/1Tablet, Orally disintegratingOralScieGen Pharmaceuticals, Inc.50228-319
LamotrigineLamotrigine 50 mg/1Tablet, Orally disintegratingOralScieGen Pharmaceuticals, Inc.50228-320
LamotrigineLamotrigine 100 mg/1Tablet, Orally disintegratingOralScieGen Pharmaceuticals, Inc.50228-321
LamotrigineLamotrigine 200 mg/1Tablet, Orally disintegratingOralScieGen Pharmaceuticals, Inc.50228-322

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