Prescription drug · NDA
Tegretol (Carbamazepine) NDC 0078-0509
Carbamazepine 200 mg/1 · Tablet · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0509-05 | 0007805090500078050905 | 100 TABLET in 1 BOTTLE (0078-0509-05)Marketed from Mar 11, 1968 | |
| 0078-0509-20 | 0007805092000078050920 | 60 TABLET in 1 BOTTLE (0078-0509-20)Marketed from Apr 6, 2017 |
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
- Generic name (nonproprietary)
- carbamazepine
- Active ingredients
- Carbamazepine — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 016608
- Marketing start
- Listing expires
- 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 0078-0509_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
N400078050905followed by a unit qualifier and the quantityPackage 00078-0509-05. 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 . 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.
About NDC 0078-0509
- What is NDC 0078-0509?
- 0078-0509 is the product NDC for Tegretol (carbamazepine), Carbamazepine 200 mg/1 tablet, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tegretol (Carbamazepine).
- What is the active ingredient?
- Carbamazepine.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tegretol?
- 1 other product NDC are listed under this name. See all Tegretol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tegretol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tegretolcarbamazepine | Carbamazepine 100 mg/5mL | SuspensionOral | Novartis Pharmaceuticals Corporation | 0078-0508 | 00078-0508-83 |