Prescription drug · NDA
Equetro (Carbamazepine) NDC 30698-419
Carbamazepine 100 mg/1 · Capsule, Extended release · Oral · Validus Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 30698-419-12 | 3069804191230698041912 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-419-12)Marketed from Dec 10, 2004 |
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)
- Equetro
- Generic name (nonproprietary)
- carbamazepine
- Active ingredients
- Carbamazepine — 100 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Validus Pharmaceuticals LLCNDC labeler code 30698
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021710
- 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 30698-419_3cbb63f0-feee-fc41-e063-6294a90a5d40SPL ID 3cbb63f0-feee-fc41-e063-6294a90a5d40SPL set ID be478f3c-40f6-47cc-8ab9-f420a9372b1cRxCUI 200131, 200133, 388311, 672908, 672909, 672910UNII 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
N430698041912followed by a unit qualifier and the quantityPackage 30698-0419-12. 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)
1INDICATIONS AND USAGE EQUETRO is: A mood stabilizer indicated for the treatment of acute manic or mixed episodes associated with bipolar I disorder ( 1.1 ) Indicated for the treatment of the pain associated with trigeminal neuralgia ( 1.2 ) An anti-epileptic drug (AED) indicated for the treatment of partial seizures with complex symptomatology, generalized tonic-clonic seizures, and mixed seizures ( 1.3 ) 1.1Acute Manic or Mixed Episodes associated with Bipolar I Disorder EQUETRO is indicated for treatment of patients with acute manic or mixed episodes associated with bipolar I disorder [see Clinical Studies ( 14.1 ) ] . 1.2 Pain of Trigeminal Neuralgia EQUETRO is indicated in the treatment…
Excerpt only. Read the full label for complete information.
About NDC 30698-419
- What is NDC 30698-419?
- 30698-419 is the product NDC for Equetro (carbamazepine), Carbamazepine 100 mg/1 capsule, extended release, listed with the FDA by Validus Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Equetro (Carbamazepine).
- What is the active ingredient?
- Carbamazepine.
- Who is the labeler?
- Validus Pharmaceuticals LLC, NDC labeler code 30698. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Equetro?
- 2 other product NDCs are listed under this name. See all Equetro NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Equetro products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Equetrocarbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | Validus Pharmaceuticals LLC | 30698-421 | 30698-0421-12 |
| Equetrocarbamazepine | Carbamazepine 300 mg/1 | Capsule, Extended releaseOral | Validus Pharmaceuticals LLC | 30698-423 | 30698-0423-12 |
Other NDCs under NDA 021710
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 |
|---|---|---|---|---|
| Equetrocarbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | Validus Pharmaceuticals LLC | 30698-421 |
| Equetrocarbamazepine | Carbamazepine 300 mg/1 | Capsule, Extended releaseOral | Validus Pharmaceuticals LLC | 30698-423 |