Prescription drug · ANDA
Carbamazepine NDC 68999-802
Carbamazepine 100 mg/5mL · Suspension · Oral · Chartwell Governmental & Specialty RX, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68999-802-24 | 6899908022468999080224 | 2 TRAY in 1 BOX (68999-802-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-802-45)Marketed from Oct 15, 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 — 100 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Chartwell Governmental & Specialty RX, LLC.NDC labeler code 68999
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075714
- 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 68999-802_41dd08a0-b89b-6ad3-e063-6394a90afdc6SPL ID 41dd08a0-b89b-6ad3-e063-6394a90afdc6SPL set ID 35298eaf-3478-4dfb-a629-298dd52713f0RxCUI 308976UNII 33CM23913M
- 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
N468999080224followed by a unit qualifier and the quantityPackage 68999-0802-24. 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 Car…
Excerpt only. Read the full label for complete information.
About NDC 68999-802
- What is NDC 68999-802?
- 68999-802 is the product NDC for Carbamazepine, Carbamazepine 100 mg/5mL suspension, listed with the FDA by Chartwell Governmental & Specialty RX, LLC.. 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?
- Chartwell Governmental & Specialty RX, LLC., NDC labeler code 68999. 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 075714
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/5mL | SuspensionOral | Chartwell RX, LLC | 62135-802 |
| Carbamazepine | Carbamazepine 200 mg/10mL | SuspensionOral | Chartwell RX, LLC | 62135-867 |
| Carbamazepine | Carbamazepine 200 mg/10mL | SuspensionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-867 |