Prescription drug · ANDA
Carbamazepine NDC 60505-0183
Carbamazepine 200 mg/1 · Tablet · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-0183-0 | 60505018300 | 100 TABLET in 1 BOTTLE (60505-0183-0)Marketed from Sep 1, 2002 | |
| 60505-0183-1 | 60505018301 | 1000 TABLET in 1 BOTTLE (60505-0183-1)Marketed from Sep 1, 2002 |
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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075948
- 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 60505-0183_8a415613-aacb-217a-cf82-67ed8f5e7cebSPL ID 8a415613-aacb-217a-cf82-67ed8f5e7cebSPL set ID bf0d012f-da14-8ce3-d74f-56172cddebc5RxCUI 308979UNII 33CM23913MUPC 0360505018307
- 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
N460505018300followed by a unit qualifier and the quantityPackage 60505-0183-00. 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 tablets 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: 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. 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 ). Trige…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075948
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 200 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1708 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Proficient Rx LP | 71205-025 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-032 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3146 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7210 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | American Health Packaging | 68084-444 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-953 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0691 |