Prescription drug · ANDA
Carbamazepine NDC 75834-220
Carbamazepine 100 mg/1 · Tablet · Oral · NIVAGEN PHARMACEUTICALS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75834-220-00 | 7583402200075834022000 | 1000 TABLET in 1 BOTTLE (75834-220-00)Marketed from Apr 21, 2020 | |
| 75834-220-01 | 7583402200175834022001 | 100 TABLET in 1 BOTTLE (75834-220-01)Marketed from Apr 21, 2020 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NIVAGEN PHARMACEUTICALS, INC.NDC labeler code 75834
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207798
- 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 75834-220_5cad93e2-6a7b-0244-e063-6294a90a5d9fSPL ID 5cad93e2-6a7b-0244-e063-6294a90a5d9f
- 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
N475834022000followed by a unit qualifier and the quantityPackage 75834-0220-00. 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 75834-220
- What is NDC 75834-220?
- 75834-220 is the product NDC for Carbamazepine, Carbamazepine 100 mg/1 tablet, listed with the FDA by NIVAGEN PHARMACEUTICALS, INC.. It has 2 package NDCs, 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?
- NIVAGEN PHARMACEUTICALS, INC., NDC labeler code 75834. 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 207798
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 | TabletOral | A-S Medication Solutions | 50090-5740 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-008 |
| Carbamazepine | Carbamazepine 100 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-034 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Coupler LLC | 67046-0707 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7825 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2841 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1730 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | direct rx | 72189-157 |
| Carbamazepine | Carbamazepine 200 mg/1 | TabletOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-221 |