Divalproex Sodium NDC 68001-106

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-106Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0106Add 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 NDC	11-digit (billing)	Package	Copy
68001-106-00	68001010600	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-106-00)Marketed from Oct 8, 2013
68001-106-03	68001010603	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-106-03)Marketed from Oct 8, 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 sodium — 500 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: BluePoint Laboratories
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078239
Marketing start: Oct 8, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 68001-106_304dd980-5e9b-d776-e063-6394a90aa9cfSPL ID 304dd980-5e9b-d776-e063-6394a90aa9cfSPL set ID 1b12c694-e120-45f6-ad28-36373e2c5378RxCUI 1099563, 1099569UNII 644VL95AO6UPC 0368001105002, 0368001106009
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

N468001010600 followed by a unit qualifier and the quantity

Package 68001-0106-00. 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 Mar 14, 2025. 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 abno…

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
Product	Strength	Form · route	Labeler	Product NDC
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	American Health Packaging	68084-310
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	American Health Packaging	68084-415
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	BluePoint Laboratories	68001-105