What is NDC 71610-707?

71610-707 is the product NDC for Divalproex Sodium, Divalproex sodium 500 mg/1 tablet, film coated, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Divalproex Sodium?

185 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Divalproex Sodium NDC 71610-707 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-707Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0707Add 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
71610-707-53	7161007075371610070753	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-53)Marketed from May 16, 2023
71610-707-60	7161007076071610070760	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-60)Marketed from May 18, 2023
71610-707-70	7161007077071610070770	120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-70)Marketed from May 16, 2023
71610-707-80	7161007078071610070780	180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-80)Marketed from May 16, 2023

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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077567
Marketing start: Feb 2, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 71610-707_391af5b8-2992-47ad-80dd-9b5c373f7ce4SPL ID 391af5b8-2992-47ad-80dd-9b5c373f7ce4SPL set ID 0f5bb45e-836b-48ce-9764-2d50edcb202cRxCUI 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

N471610070753 followed by a unit qualifier and the quantity

Package 71610-0707-53. 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 May 19, 2023. 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)

About NDC 71610-707

What is NDC 71610-707?: 71610-707 is the product NDC for Divalproex Sodium, Divalproex sodium 500 mg/1 tablet, film coated, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Divalproex Sodium.
What is the active ingredient?: Divalproex sodium.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Divalproex Sodium?: 185 other product NDCs are listed under this name. See all Divalproex Sodium NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Divalproex Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	Coupler LLC	67046-1696	67046-1696-03
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Delayed releaseOral	Cardinal Health 107, LLC	55154-0577	55154-0577-00
divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-4193	68788-4193-0368788-4193-0668788-4193-09
divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Delayed releaseOral	Coupler LLC	67046-1683	67046-1683-03
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Delayed releaseOral	Unit Dose Solutions, Inc.	87441-027	87441-0027-01
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Delayed releaseOral	Unit Dose Solutions, Inc.	87441-028	87441-0028-01
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-2021	67046-2021-03
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-4100	68788-4100-0368788-4100-0668788-4100-09
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	Safecor Health, LLC	48433-033	48433-0033-08
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	Safecor Health, LLC	48433-034	48433-0034-08

All 186 Divalproex Sodium NDCs

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 500 mg/1	Tablet, Film coated, Extended releaseOral	Mylan Pharmaceuticals Inc.	0378-0473
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 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
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-030