Prescription drug · ANDA
Carbamazepine NDC 0615-8125
Carbamazepine 100 mg/1 · Tablet, Chewable · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8125-39 | 0061581253900615812539 | 30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8125-39)Marketed from Jun 6, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 100 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075687
- 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 0615-8125_b49f7644-5e05-4003-a1a8-d1ab9d7c6228SPL ID b49f7644-5e05-4003-a1a8-d1ab9d7c6228
- 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
N400615812539followed by a unit qualifier and the quantityPackage 00615-8125-39. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0615-8125
- What is NDC 0615-8125?
- 0615-8125 is the product NDC for Carbamazepine, Carbamazepine 100 mg/1 tablet, chewable, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. 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?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 075687
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, ChewableOral | Sun Pharmaceutical Industries, Inc. | 51672-4041 |
| Carbamazepine | Carbamazepine 200 mg/1 | Tablet, ChewableOral | Sun Pharmaceutical Industries, Inc. | 51672-4050 |
| Carbamazepine | Carbamazepine 100 mg/1 | Tablet, ChewableOral | Golden State Medical Supply, Inc. | 60429-934 |
| Carbamazepine | Carbamazepine 100 mg/1 | Tablet, ChewableOral | REMEDYREPACK INC. | 70518-1433 |
| Carbamazepine | Carbamazepine 100 mg/1 | Tablet, ChewableOral | REMEDYREPACK INC. | 70518-2426 |