Tegretol XR (carbamazepine) NDC 0078-0511

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0511Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0511Add 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
0078-0511-05	00078051105	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0511-05)Marketed from Mar 25, 1996

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): Tegretol XRSuffix: XR
Generic name (nonproprietary): carbamazepine
Active ingredients: Carbamazepine — 200 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Novartis Pharmaceuticals Corporation
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020234
Marketing start: Mar 25, 1996
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 0078-0511_ac037b7c-7ff9-415e-9870-963f9bbf79a7SPL ID ac037b7c-7ff9-415e-9870-963f9bbf79a7SPL set ID 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053RxCUI 199378, 308971, 308972, 308976, 308979, 402505, 402506, 866303, 866305, 866307UNII 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

N400078051105 followed by a unit qualifier and the quantity

Package 00078-0511-05. 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 20, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Epilepsy Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol 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 improvement 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 Tegretol (see PRECAUTIONS, General). Trigeminal Neuralgia Tegretol is indicat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020234

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

FDA NDC Directory listings under NDA 020234
Product	Strength	Form · route	Labeler	Product NDC
Tegretol XRcarbamazepine	Carbamazepine 100 mg/1	Tablet, Extended releaseOral	Novartis Pharmaceuticals Corporation	0078-0510
Tegretol XRcarbamazepine	Carbamazepine 400 mg/1	Tablet, Extended releaseOral	Novartis Pharmaceuticals Corporation	0078-0512