NDC codes

FDA NDC Directory
Product NDC (as listed)68001-106Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0106Add 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
68001-106-006800101060068001010600100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-106-00)Marketed from Oct 8, 2013
68001-106-036800101060368001010603500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-106-03)Marketed from Oct 8, 2013

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
BluePoint LaboratoriesNDC labeler code 68001
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078239
Marketing start
Marketing end
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 68001-106_5d66a152-de4e-011d-e063-6394a90a420fSPL ID 5d66a152-de4e-011d-e063-6394a90a420f
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

N468001010600 followed by a unit qualifier and the quantity

Package 68001-0106-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68001-106

What is NDC 68001-106?
68001-106 is the product NDC for Divalproex Sodium, Divalproex sodium 500 mg/1 tablet, film coated, extended release, listed with the FDA by BluePoint Laboratories. 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?
BluePoint Laboratories, NDC labeler code 68001. 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 078239

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

FDA NDC Directory listings under ANDA 078239
ProductStrengthForm · routeLabelerProduct NDC
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralBluePoint Laboratories68001-105
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralAmerican Health Packaging68084-310
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralAmerican Health Packaging68084-415

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