Prescription drug · NDA
Carbatrol (Carbamazepine) NDC 54092-173
Carbamazepine 300 mg/1 · Capsule, Extended release · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54092-173-12 | 5409201731254092017312 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-173-12)Marketed from Sep 30, 1997 |
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 — 300 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 54092
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020712
- 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 54092-173_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
N454092017312followed by a unit qualifier and the quantityPackage 54092-0173-12. 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 . 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.
About NDC 54092-173
- What is NDC 54092-173?
- 54092-173 is the product NDC for Carbatrol (carbamazepine), Carbamazepine 300 mg/1 capsule, extended release, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carbatrol (Carbamazepine).
- What is the active ingredient?
- Carbamazepine.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 54092. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Carbatrol?
- 2 other product NDCs are listed under this name. See all Carbatrol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Carbatrol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Carbatrolcarbamazepine | Carbamazepine 100 mg/1 | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-171 | 54092-0171-12 |
| Carbatrolcarbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-172 | 54092-0172-12 |
Other NDCs under NDA 020712
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Carbatrolcarbamazepine | Carbamazepine 100 mg/1 | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-171 |
| Carbatrolcarbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | Takeda Pharmaceuticals America, Inc. | 54092-172 |