Prescription drug · ANDA
Carbamazepine ER NDC 62135-928
Carbamazepine 200 mg/1 · Tablet, Extended release · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-928-60 | 62135092860 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-928-60)Marketed from Nov 6, 2024 |
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 er
- Active ingredients
- Carbamazepine — 200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- 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 62135-928_458c15a3-d257-681b-e063-6294a90a282aSPL ID 458c15a3-d257-681b-e063-6294a90a282aSPL set ID bf2bff52-d1ae-4b81-951c-7d39d3c5058fRxCUI 199378, 402505, 402506UNII 33CM23913MUPC 0362135930608, 0362135928605, 0362135927608
- 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
N462135092860followed by a unit qualifier and the quantityPackage 62135-0928-60. 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
Excerpt only. Read the full label for complete information.
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 400 mg/1 | Tablet, Extended releaseOral | Bostal LLC | 35561-357 |
| Carbamazepine ER | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-927 |
| Carbamazepine ER | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-930 |
| Carbamazepine ERcarbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Bostal LLC | 35561-356 |
| Carbamazepine ERcarbamazepine | Carbamazepine 100 mg/1 | Tablet, Extended releaseOral | Bostal LLC | 35561-355 |