NDC codes

FDA NDC Directory
Product NDC (as listed)68382-106Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0106Add 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
68382-106-016838201060168382010601100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-106-01)Marketed from Jan 27, 2009
68382-106-1068382010610683820106101000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-106-10)Marketed from Jan 27, 2009
68382-106-776838201067768382010677100 BLISTER PACK in 1 CARTON (68382-106-77) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-106-30)Marketed from Jan 27, 2009

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 — 125 mg/1
Dosage form
Capsule, Coated pellets
Route
Oral
Labeler
Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078919
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 68382-106_3b089c0e-35d2-40ed-a4ad-7c9c32c391beSPL ID 3b089c0e-35d2-40ed-a4ad-7c9c32c391beSPL set ID ed710c62-8ba6-4f19-b240-3ee73cd03d67RxCUI 1099596UNII 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

N468382010601 followed by a unit qualifier and the quantity

Package 68382-0106-01. 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 delayed-release capsules are an anti-epileptic drug indicated for: 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 ) 1.1 Epilepsy Divalproex sodium delayed-release capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release capsules are also indicated for use as sole and adjunctive therapy in the treat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-106

What is NDC 68382-106?
68382-106 is the product NDC for divalproex sodium, Divalproex sodium 125 mg/1 capsule, coated pellets, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 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?
Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 078919

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

FDA NDC Directory listings under ANDA 078919
ProductStrengthForm · routeLabelerProduct NDC
divalproex sodiumDivalproex sodium 125 mg/1Capsule, Coated pelletsOralATLANTIC BIOLOGICALS CORP.17856-0109
Divalproex SodiumDivalproex sodium 125 mg/1Capsule, Coated pelletsOralCardinal Health 107, LLC55154-4759
divalproex sodiumDivalproex sodium 125 mg/1Capsule, Coated pelletsOralZydus Lifesciences Limited65841-639
Divalproex SodiumDivalproex sodium 125 mg/1Capsule, Coated pelletsOralAmerican Health Packaging68084-313
divalproex sodiumDivalproex sodium 125 mg/1Capsule, Coated pelletsOralREMEDYREPACK INC.70518-1749

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