Equetro Capsule, Extended Release
NDC Package 30698-421-12
Package Information
Equetro (carbamazepine) capsules is carbamazepine is used to prevent and control seizures. This formulation utilizes a capsule, extended release delivery system. Marketed by Validus Pharmaceuticals Llc, this product is identified by NDC 30698-421 and is authorized under FDA application NDA021710.
Identification & Billing
- RxCUI: 200131 - carBAMazepine 300 MG 12HR Extended Release Oral Capsule
- RxCUI: 200131 - 12 HR carbamazepine 300 MG Extended Release Oral Capsule
- RxCUI: 200131 - carbamazepine 300 MG 12 HR Extended Release Oral Capsule
- RxCUI: 200133 - carBAMazepine 200 MG 12HR Extended Release Oral Capsule
- RxCUI: 200133 - 12 HR carbamazepine 200 MG Extended Release Oral Capsule
Clinical Specifications
- Cytochrome P450 1A2 Inducers - [MoA] (Mechanism of Action)
- Cytochrome P450 2B6 Inducers - [MoA] (Mechanism of Action)
- Cytochrome P450 2C19 Inducers - [MoA] (Mechanism of Action)
- Cytochrome P450 2C9 Inducers - [MoA] (Mechanism of Action)
- Cytochrome P450 3A4 Inducers - [MoA] (Mechanism of Action)
- Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
- Mood Stabilizer - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 30698 - Validus Pharmaceuticals Llc
- 30698-421 - Equetro
- 30698-421-12 - 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
- 30698-421 - Equetro
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 30698-421-12 identifies a specific commercial package of 120 capsule, extended release in 1 bottle of Equetro, a human prescription drug labeled by Validus Pharmaceuticals Llc. This capsule, extended release is formulated for oral use and contains carbamazepine as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Validus Pharmaceuticals Llc on December 10, 2004. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia). This medication works by reducing the spread of seizure activity in the brain and restoring the normal balance of nerve activity. Some forms of this medication are also used to treat bipolar disorder. Carbamazepine can help to decrease extreme changes in mood and help you feel less agitated.
How is this Validus Pharmaceuticals Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 30698042112. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.