Prescription drug · ANDA
Carbamazepine NDC 60505-2807
Carbamazepine 300 mg/1 · Capsule, Extended release · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-2807-7 | 60505280707 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2807-7)Marketed from Mar 23, 2012 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 300 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078986
- 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 60505-2807_c24e1663-4df1-d5a1-f9ed-551ba3552575SPL ID c24e1663-4df1-d5a1-f9ed-551ba3552575SPL set ID e91f9de3-3fdd-0a6b-71ce-53a2cc142816RxCUI 200131, 200133, 388311UNII 33CM23913MUPC 0360505280674, 0360505280575
- 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
N460505280707followed by a unit qualifier and the quantityPackage 60505-2807-07. 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 extended-release capsules are 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078986
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 300 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4492 |
| Carbamazepine | Carbamazepine 100 mg/1 | Capsule, Extended releaseOral | Apotex Corp. | 60505-2805 |
| Carbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | Apotex Corp. | 60505-2806 |
| Carbamazepine | Carbamazepine 100 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2921 |
| Carbamazepine | Carbamazepine 300 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2707 |
| Carbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2706 |
| Carbamazepine | Carbamazepine 100 mg/1 | Capsule, Extended releaseOral | AvPAK | 50268-170 |
| Carbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | AvPAK | 50268-171 |
| Carbamazepine | Carbamazepine 300 mg/1 | Capsule, Extended releaseOral | AvPAK | 50268-172 |
| Carbamazepine | Carbamazepine 300 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-3001 |
| Carbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-3002 |
| Carbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | Major Pharmaceuticals | 0904-6885 |
| Carbamazepine | Carbamazepine 300 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1715 |
| Carbamazepine | Carbamazepine 100 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-3077 |