Prescription drug · ANDA
carbamazepine NDC 70771-1469
Carbamazepine 200 mg/1 · Tablet, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1469-1 | 70771146901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1469-1)Marketed from Mar 12, 2019 | |
| 70771-1469-3 | 70771146903 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1469-3)Marketed from Mar 12, 2019 | |
| 70771-1469-4 | 70771146904 | 10 BLISTER PACK in 1 CARTON (70771-1469-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 12, 2019 | |
| 70771-1469-9 | 70771146909 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1469-9)Marketed from Mar 12, 2019 |
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, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205571
- 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 70771-1469_888a57e4-5129-4f43-888b-126f37be3954SPL ID 888a57e4-5129-4f43-888b-126f37be3954SPL set ID d10e5f83-56db-4bc9-8c51-150a2e3e20eaRxCUI 199378, 402505, 402506UNII 33CM23913MUPC 0370771146819
- 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
N470771146901followed by a unit qualifier and the quantityPackage 70771-1469-01. 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 extended-release tablets are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine extended-release tablets 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 ex…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205571
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 | Tablet, Extended releaseOral | Northstar Rx LLC | 16714-064 |
| carbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC | 16714-063 |
| carbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-555 |
| carbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-556 |
| carbamazepine | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-557 |
| carbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1468 |
| carbamazepine | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1470 |