Divalproex Sodium NDC 0378-0473

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0473Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0473Add 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
0378-0473-01	00378047301	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-01)Marketed from Feb 2, 2009
0378-0473-05	00378047305	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-05)Marketed from Feb 2, 2009

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077567
Marketing start: Feb 2, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 0378-0473_346235bd-f9cb-4693-9ad2-d62cbe9c62efSPL ID 346235bd-f9cb-4693-9ad2-d62cbe9c62efSPL set ID 00332c65-edad-a153-9c78-628931daa732RxCUI 1099563, 1099569UNII 644VL95AO6UPC 0303780473010, 0303780472013
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

N400378047301 followed by a unit qualifier and the quantity

Package 00378-0473-01. 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 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 a 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 persis…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077567

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

FDA NDC Directory listings under ANDA 077567
Product	Strength	Form · route	Labeler	Product NDC
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	Mylan Pharmaceuticals Inc.	0378-0472
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-030
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	Safecor Health, LLC	48433-033
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	Safecor Health, LLC	48433-034
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-707
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	Mylan Institutional Inc.	51079-766
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	Mylan Institutional Inc.	51079-767