Prescription drug · ANDA
Carbamazepine NDC 63629-8753
Carbamazepine 200 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8753-1 | 63629875301 | 1000 TABLET in 1 BOTTLE (63629-8753-1)Marketed from Aug 20, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070541
- 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 63629-8753_3b67c5f2-b7be-45f7-964d-4105ec2e4676SPL ID 3b67c5f2-b7be-45f7-964d-4105ec2e4676SPL set ID ebcffad6-da03-43f4-a75b-7de13e94bb7dRxCUI 308979UNII 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
N463629875301followed by a unit qualifier and the quantityPackage 63629-8753-01. 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 tablets and carbamazepine tablets (chewable) are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine tablets and carbamazepine tablets (chewable) 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 app…
Excerpt only. Read the full label for complete information.
About NDC 63629-8753
- What is NDC 63629-8753?
- 63629-8753 is the product NDC for Carbamazepine, Carbamazepine 200 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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?
- 131 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/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 100 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC | 72603-886 | 72603-0886-01 |
| Carbamazepine | Carbamazepine 200 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC | 72603-887 | 72603-0887-01 |
| Carbamazepine | Carbamazepine 400 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC | 72603-888 | 72603-0888-01 |