NDC codes

FDA NDC Directory
Product NDC (as listed)31722-021Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0021Add 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
31722-021-0131722002101100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-021-01)Marketed from Sep 26, 2023
31722-021-0531722002105500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-021-05)Marketed from Sep 26, 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 — 250 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215527
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 31722-021_55afb95d-873d-2adb-e063-6294a90a2e3dSPL ID 55afb95d-873d-2adb-e063-6294a90a2e3dSPL set ID e8e954d4-54e3-491c-867c-b3b656b70f23RxCUI 1099563, 1099569UNII 644VL95AO6UPC 0331722022057, 0331722022019, 0331722021012
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

N431722002101 followed by a unit qualifier and the quantity

Package 31722-0021-01. 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 . 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 31722-021

What is NDC 31722-021?
31722-021 is the product NDC for Divalproex sodium, Divalproex sodium 250 mg/1 tablet, film coated, extended release, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 2 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?
Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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?
184 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 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
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralREMEDYREPACK INC.70518-457570518-4575-00
divalproex sodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-407968788-4079-0368788-4079-0668788-4079-09

All 185 Divalproex sodium NDCs

Other NDCs under ANDA 215527

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

FDA NDC Directory listings under ANDA 215527
ProductStrengthForm · routeLabelerProduct NDC
Divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-2535
Divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralCamber Pharmaceuticals, Inc.31722-022

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