Prescription drug · ANDA
Carbamazepine NDC 67877-799
Carbamazepine 400 mg/1 · Tablet, Extended release · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-799-01 | 67877079901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-799-01)Marketed from Nov 1, 2025 | |
| 67877-799-05 | 67877079905 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-799-05)Marketed from Nov 1, 2025 | |
| 67877-799-30 | 67877079930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-799-30)Marketed from Nov 1, 2025 | |
| 67877-799-33 | 67877079933 | 1 BLISTER PACK in 1 CARTON (67877-799-33) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 1, 2025 |
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
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217277
- 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 67877-799_81d3a7f0-51cf-48cc-935f-770a84223619SPL ID 81d3a7f0-51cf-48cc-935f-770a84223619SPL set ID f0a254c5-bd33-4b14-b9f0-830b3438f5c6RxCUI 199378, 402505, 402506UNII 33CM23913MUPC 0367877799056
- 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
N467877079901followed by a unit qualifier and the quantityPackage 67877-0799-01. 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 & 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: 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 carbamaze…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217277
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 | Ascend Laboratories, LLC | 67877-797 |
| Carbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-798 |