Prescription drug · ANDA
Carbamazepine NDC 51407-895
Carbamazepine 100 mg/1 · Tablet, Extended release · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-895-01 | 51407089501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-895-01)Marketed from Mar 20, 2024 |
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)
- Carbamazepine
- Generic name (nonproprietary)
- carbamazepine
- Active ingredients
- Carbamazepine — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078115
- 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 51407-895_4b219175-e01f-8e98-e063-6294a90a12e6SPL ID 4b219175-e01f-8e98-e063-6294a90a12e6SPL set ID 1922a7cd-6a43-dab5-e063-6294a90a3d8fRxCUI 199378, 402505, 402506UNII 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
N451407089501followed by a unit qualifier and the quantityPackage 51407-0895-01. 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 Carbamazepine 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 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 carbamazepine (see PRECAUTIONS, General ). Trigeminal Neuralgia Car…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078115
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 |
|---|---|---|---|---|
| Carbamazepine | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Coupler, LLC | 67046-1534 |
| Carbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 51672-4124 |
| Carbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 51672-4123 |
| Carbamazepine | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 51672-4125 |
| Carbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-896 |
| Carbamazepine | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-897 |