Prescription drug · ANDA
Carbamazepine ER (Carbamazepine) NDC 35561-357
Carbamazepine 400 mg/1 · Tablet, Extended release · Oral · Bostal LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35561-357-12 | 3556103571235561035712 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-357-12)Marketed from Mar 31, 2022 | |
| 35561-357-13 | 3556103571335561035713 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-357-13)Marketed from Apr 9, 2025 | |
| 35561-357-99 | 3556103579935561035799 | 33051 TABLET, EXTENDED RELEASE in 1 DRUM (35561-357-99)Marketed from Apr 27, 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 ER
- Generic name (nonproprietary)
- carbamazepine
- Active ingredients
- Carbamazepine — 400 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bostal LLCNDC labeler code 35561
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215591
- 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 35561-357_5094cfb0-cf09-008b-e063-6394a90a402fSPL ID 5094cfb0-cf09-008b-e063-6394a90a402fSPL set ID b48741b3-0889-47b8-a26e-b12614f6e7fcRxCUI 199378, 402505, 402506UNII 33CM23913MUPC 0335561357134, 0335561355260, 0335561356137, 0335561356267, 0335561357127, 0335561357264
- 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
N435561035712followed by a unit qualifier and the quantityPackage 35561-0357-12. 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 Carb…
Excerpt only. Read the full label for complete information.
About NDC 35561-357
- What is NDC 35561-357?
- 35561-357 is the product NDC for Carbamazepine ER (carbamazepine), Carbamazepine 400 mg/1 tablet, extended release, listed with the FDA by Bostal LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carbamazepine ER (Carbamazepine).
- What is the active ingredient?
- Carbamazepine.
- Who is the labeler?
- Bostal LLC, NDC labeler code 35561. 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 ER?
- 10 other product NDCs are listed under this name. See all Carbamazepine ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Carbamazepine ER 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 ERcarbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Oryza Pharmaceuticals Inc. | 72516-020 | 72516-0020-01 |
| Carbamazepine ERcarbamazepine | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Oryza Pharmaceuticals Inc. | 72516-021 | 72516-0021-01 |
| Carbamazepine ERcarbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Epic Pharma, LLC | 42806-275 | 42806-0275-01 |
| Carbamazepine ERcarbamazepine | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Epic Pharma, LLC | 42806-276 | 42806-0276-01 |
| Carbamazepine ERcarbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Epic Pharma, LLC | 42806-274 | 42806-0274-01 |
| Carbamazepine ERcarbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Bostal LLC | 35561-355 | 35561-0355-1235561-0355-1335561-0355-99 |
| Carbamazepine ERcarbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Bostal LLC | 35561-356 | 35561-0356-1235561-0356-1335561-0356-99 |
| Carbamazepine ER | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-927 | 62135-0927-60 |
| Carbamazepine ER | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-928 | 62135-0928-60 |
| Carbamazepine ER | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-930 | 62135-0930-60 |
Other NDCs under ANDA 215591
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 ERcarbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Bostal LLC | 35561-355 |
| Carbamazepine ERcarbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Bostal LLC | 35561-356 |
| Carbamazepine ER | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-927 |
| Carbamazepine ER | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-928 |
| Carbamazepine ER | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-930 |