Prescription drug · ANDA
Carbamazepine NDC 50742-259
Carbamazepine 400 mg/1 · Tablet, Extended release · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-259-01 | 5074202590150742025901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-259-01)Marketed from Aug 1, 2023 |
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 — 400 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Ingenus Pharmaceuticals, LLCNDC labeler code 50742
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216404
- 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 50742-259_51f0f49a-c1ef-4ccd-8872-001241d81f81SPL ID 51f0f49a-c1ef-4ccd-8872-001241d81f81SPL set ID de67de85-15b3-4c27-b604-d028ce3789d0RxCUI 199378, 402505, 402506UNII 33CM23913MUPC 0350742258017, 0350742259014, 0350742257010
- 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
N450742025901followed by a unit qualifier and the quantityPackage 50742-0259-01. 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: 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.
About NDC 50742-259
- What is NDC 50742-259?
- 50742-259 is the product NDC for Carbamazepine, Carbamazepine 400 mg/1 tablet, extended release, listed with the FDA by Ingenus Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carbamazepine.
- What is the active ingredient?
- Carbamazepine.
- Who is the labeler?
- Ingenus Pharmaceuticals, LLC, NDC labeler code 50742. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Carbamazepine?
- 133 other product NDCs are listed under this name. See all Carbamazepine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Carbamazepine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Carbamazepine | Carbamazepine 100 mg/5mL | SuspensionOral | Precision Dose, Inc. | 68094-125 | 68094-0125-62 |
| Carbamazepine | Carbamazepine 100 mg/5mL | SuspensionOral | Precision Dose, Inc. | 68094-225 | 68094-0225-62 |
| Carbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-973 | 60687-0973-21 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4682 | 70518-4682-00 |
| Carbamazepine | Carbamazepine 100 mg/1 | Tablet, ChewableOral | Coupler LLC | 67046-0753 | 67046-0753-03 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Coupler LLC | 67046-0707 | 67046-0707-03 |
| Carbamazepine | Carbamazepine 100 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-484 | 62559-0484-12 |
| Carbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-485 | 62559-0485-12 |
| Carbamazepine | Carbamazepine 300 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-486 | 62559-0486-12 |
| Carbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC | 72603-887 | 72603-0887-01 |
Other NDCs under ANDA 216404
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 | Ingenus Pharmaceuticals, LLC | 50742-257 |
| Carbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-258 |