Prescription drug · ANDA

Divalproex sodium NDC 71610-249

Divalproex sodium 500 mg/1 · Tablet, Film coated, Extended release · Oral · Aphena Pharma Solutions - Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)71610-249Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0249Add 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 NDC11-digit (billing)PackageCopy
71610-249-30716100249307161002493030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-30)Marketed from Sep 15, 2020
71610-249-53716100249537161002495360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-53)Marketed from Mar 14, 2019
71610-249-60716100249607161002496090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-60)Marketed from Mar 14, 2019
71610-249-707161002497071610024970120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-70)Marketed from Mar 14, 2019
71610-249-747161002497471610024974500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-74)Marketed from Jun 12, 2026
71610-249-807161002498071610024980180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-80)Marketed from Oct 9, 2020

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 202419
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 71610-249_544d8f87-38bd-4d78-e063-6294a90a2a67SPL ID 544d8f87-38bd-4d78-e063-6294a90a2a67SPL set ID 41e32cd5-1393-4ef1-81cb-8e3795e30682RxCUI 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

N471610024930 followed by a unit qualifier and the quantity

Package 71610-0249-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Divalproex sodium extended-release tablets are an anti-epileptic drug 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-249

What is NDC 71610-249?
71610-249 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 6 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
divalproex sodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralCoupler LLC67046-169667046-1696-03
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralCardinal Health 107, LLC55154-057755154-0577-00
divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralPreferred Pharmaceuticals Inc.68788-419368788-4193-0368788-4193-0668788-4193-09
divalproex sodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralCoupler LLC67046-168367046-1683-03
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralUnit Dose Solutions, Inc.87441-02787441-0027-01
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralUnit Dose Solutions, Inc.87441-02887441-0028-01
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Extended releaseOralCoupler LLC67046-202167046-2021-03
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-410068788-4100-0368788-4100-0668788-4100-09
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralSafecor Health, LLC48433-03348433-0033-08
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralSafecor Health, LLC48433-03448433-0034-08

All 186 Divalproex sodium NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Divalproex sodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-2515
Divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-2516
Divalproex sodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-157
Divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-205
Divalproex sodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited65862-594
Divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited65862-595
Divalproex sodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralREMEDYREPACK INC.70518-1781
Divalproex sodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-289
Divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralREMEDYREPACK INC.70518-1897
Divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralREMEDYREPACK INC.70518-2003
Divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralA-S Medication Solutions50090-4737
Divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralA-S Medication Solutions50090-6074
Divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-4698
Divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralNorthStar Rx LLC16714-485
Divalproex sodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralNorthStar Rx LLC16714-484

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