Divalproex sodium NDC 68788-8358

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8358Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8358Add 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
68788-8358-3	68788835803	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8358-3)Marketed from Feb 13, 2023
68788-8358-6	68788835806	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8358-6)Marketed from Feb 13, 2023
68788-8358-9	68788835809	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8358-9)Marketed from Feb 13, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Extended release
Route: Oral
Labeler: Preferred Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209286
Marketing start: Feb 13, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 68788-8358_8640d1fe-87c9-412e-99db-8f4298277daaSPL ID 8640d1fe-87c9-412e-99db-8f4298277daaSPL set ID 83a77f60-ed58-4fa0-a584-e6a0c767d19dRxCUI 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

N468788835803 followed by a unit qualifier and the quantity

Package 68788-8358-03. 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 Apr 8, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

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 and persistent…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209286

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

FDA NDC Directory listings under ANDA 209286
Product	Strength	Form · route	Labeler	Product NDC
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-286
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-3183
Divalproex Sodium ER	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	Direct_Rx	72189-459
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-1883
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Extended releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8376
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8377
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-260
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-261
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-3477