Carbatrol (carbamazepine) NDC 54092-171

NDC codes

FDA NDC Directory

Product NDC (as listed)54092-171Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54092-0171Add 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
54092-171-12	54092017112	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-171-12)Marketed from Dec 22, 1999

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): Carbatrol
Generic name (nonproprietary): carbamazepine
Active ingredients: Carbamazepine — 100 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Takeda Pharmaceuticals America, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020712
Marketing start: Dec 22, 1999
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 1A2 Inducers (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 54092-171_4186c118-9875-4b12-b652-3fbfaf4e6622SPL ID 4186c118-9875-4b12-b652-3fbfaf4e6622SPL set ID bc03e499-5bac-4293-bff4-6864153a624dRxCUI 200131, 200133, 308977, 313931, 388311, 404742UNII 33CM23913M
Pharmacologic class: 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

N454092017112 followed by a unit qualifier and the quantity

Package 54092-0171-12. 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 17, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Epilepsy Carbatrol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types. Generalized tonic-clonic seizures (grand mal). Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General ). Trigeminal Neuralgia Carbat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020712

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

FDA NDC Directory listings under NDA 020712
Product	Strength	Form · route	Labeler	Product NDC
Carbatrolcarbamazepine	Carbamazepine 200 mg/1	Capsule, Extended releaseOral	Takeda Pharmaceuticals America, Inc.	54092-172
Carbatrolcarbamazepine	Carbamazepine 300 mg/1	Capsule, Extended releaseOral	Takeda Pharmaceuticals America, Inc.	54092-173