NDC codes

FDA NDC Directory
Product NDC (as listed)68084-313Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68084-0313Add 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
68084-313-016808403130168084031301100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-313-01) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68084-313-11)Marketed from Mar 18, 2009
68084-313-65680840313656808403136550 BLISTER PACK in 1 CARTON (68084-313-65) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68084-313-11)Marketed from Jun 26, 2024

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
American Health PackagingNDC labeler code 68084
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 68084-313_337704d6-7d3c-1fee-e063-6394a90a664bSPL ID 337704d6-7d3c-1fee-e063-6394a90a664bSPL set ID 2e4778d8-8798-4da1-bb33-1aa1414b5809RxCUI 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

N468084031301 followed by a unit qualifier and the quantity

Package 68084-0313-01. 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 treatme…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68084-313

What is NDC 68084-313?
68084-313 is the product NDC for Divalproex Sodium, Divalproex sodium 125 mg/1 capsule, coated pellets, listed with the FDA by American Health Packaging. 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?
American Health Packaging, NDC labeler code 68084. 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 pelletsOralZydus Pharmaceuticals USA Inc.68382-106
divalproex sodiumDivalproex sodium 125 mg/1Capsule, Coated pelletsOralREMEDYREPACK INC.70518-1749

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