NDC codes

FDA NDC Directory
Product NDC (as listed)68084-310Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68084-0310Add 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
68084-310-0168084031001100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-310-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-310-11)Marketed from Nov 21, 2013

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)
Divalproex Sodium
Generic name (nonproprietary)
divalproex sodium
Active ingredients
Divalproex sodium250 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078239
Marketing start
Marketing end
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 68084-310_46405f96-5e81-a0c9-e063-6394a90a9592SPL ID 46405f96-5e81-a0c9-e063-6394a90a9592SPL set ID a8ba3986-1ded-44a8-8d10-d0f252a07794RxCUI 1099563, 1099569UNII 644VL95AO6
Pharmacologic class
Anti-epileptic Agent; 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

N468084031001 followed by a unit qualifier and the quantity

Package 68084-0310-01. 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)

1. INDICATIONS AND USAGE Divalproex sodium extended-release tablets are indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2) Prophylaxis of migraine headaches (1.3) 1.1 Mania Divalproex sodium extended-release tablets are valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078239

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

FDA NDC Directory listings under ANDA 078239
ProductStrengthForm · routeLabelerProduct NDC
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralAmerican Health Packaging68084-415
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralBluePoint Laboratories68001-105
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralBluePoint Laboratories68001-106

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