Prescription drug · ANDA
Carbamazepine NDC 75834-221
Carbamazepine 200 mg/1 · Tablet · Oral · NIVAGEN PHARMACEUTICALS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75834-221-00 | 75834022100 | 1000 TABLET in 1 BOTTLE (75834-221-00)Marketed from Apr 21, 2020 | |
| 75834-221-01 | 75834022101 | 100 TABLET in 1 BOTTLE (75834-221-01)Marketed from Apr 21, 2020 |
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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207798
- 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 75834-221_45806c19-4811-987e-e063-6394a90aa8faSPL ID 45806c19-4811-987e-e063-6394a90aa8faSPL set ID e68998cb-5f91-4d7e-85a6-555efb8b0384RxCUI 197441, 308979UNII 33CM23913MUPC 0375834220017, 0375834221014, 0375834220000, 0375834221007
- 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
N475834022100followed by a unit qualifier and the quantityPackage 75834-0221-00. 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 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: 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). Trigeminal Neur…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207798
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 100 mg/1 | TabletOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-220 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | direct rx | 72189-157 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Coupler LLC | 67046-0707 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-5740 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7825 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1730 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-008 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2841 |
| Carbamazepine | Carbamazepine 100 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-034 |