Divalproex sodium NDC 71610-289

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-289Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0289Add 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
71610-289-30	71610028930	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-30)Marketed from Jun 5, 2019
71610-289-60	71610028960	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-60)Marketed from Jun 5, 2019
71610-289-75	71610028975	150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-75)Marketed from Jun 5, 2019
71610-289-80	71610028980	180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-80)Marketed from Sep 3, 2024
71610-289-92	71610028992	270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-92)Marketed from Sep 3, 2024

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 — 250 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202419
Marketing start: Jun 2, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 71610-289_214cf544-a872-5727-e063-6294a90a5843SPL ID 214cf544-a872-5727-e063-6294a90a5843SPL set ID 9a9f5f24-e421-406f-ac91-d1f964245f54RxCUI 1099563UNII 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

N471610028930 followed by a unit qualifier and the quantity

Package 71610-0289-30. 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 Sep 4, 2024. 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 persistently eleva…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202419

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

FDA NDC Directory listings under ANDA 202419
Product	Strength	Form · route	Labeler	Product NDC
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	65862-594
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	65862-595
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-1781
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-2003
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	63629-4698
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	72162-2516
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	72162-2515
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-4737
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-1897
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-157
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-6074
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-205
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-249
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	NorthStar Rx LLC	16714-484
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	NorthStar Rx LLC	16714-485