Prescription drug · ANDA
Carbamazepine NDC 60290-059
Carbamazepine 200 mg/1 · Tablet, Extended release · Oral · Umedica Laboratories USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60290-059-01 | 60290005901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-059-01)Marketed from Aug 20, 2022 | |
| 60290-059-02 | 60290005902 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-059-02)Marketed from Aug 20, 2022 |
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, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216594
- 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 60290-059_58d8e5da-6539-09a3-e063-6394a90a38e0SPL ID 58d8e5da-6539-09a3-e063-6394a90a38e0SPL set ID 48080efd-1781-4585-83f8-c43957ac63b3RxCUI 199378, 402505, 402506UNII 33CM23913MUPC 0360290058014, 0360290058021, 0360290060024, 0360290059028
- 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
N460290005901followed by a unit qualifier and the quantityPackage 60290-0059-01. 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 Ca…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216594
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 | Tablet, Extended releaseOral | Umedica Laboratories USA Inc. | 60290-058 |
| Carbamazepine | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Umedica Laboratories USA Inc. | 60290-060 |
| Carbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3773 |
| Carbamazepine | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3911 |
| Carbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-973 |
| Carbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-5914 |
| Carbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-790 |
| Carbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-789 |
| Carbamazepine | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-791 |
| Carbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3699 |
| Carbamazepine | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC | 72603-888 |
| Carbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC | 72603-886 |
| Carbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC | 72603-887 |