NDC codes

FDA NDC Directory
Product NDC (as listed)30698-421Labeler and product segments. Claims need a package NDC.
Product NDC at billing width30698-0421Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
30698-421-1230698042112120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-421-12)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 — 200 mg/1
Dosage form
Capsule, Extended release
Route
Oral
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 30698-421_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

N430698042112 followed by a unit qualifier and the quantity

Package 30698-0421-12. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021710

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021710
ProductStrengthForm · routeLabelerProduct NDC
EquetrocarbamazepineCarbamazepine 100 mg/1Capsule, Extended releaseOralValidus Pharmaceuticals LLC30698-419
EquetrocarbamazepineCarbamazepine 300 mg/1Capsule, Extended releaseOralValidus Pharmaceuticals LLC30698-423

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