NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6615Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6615Add 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
0904-6615-6100904661561100 BLISTER PACK in 1 CARTON (0904-6615-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jan 23, 2009

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078979
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 0904-6615_c1a36c17-70aa-4acb-bea6-420523e80744SPL ID c1a36c17-70aa-4acb-bea6-420523e80744SPL set ID 4a0fa934-ec8c-460e-86eb-11281728fe85RxCUI 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

N400904661561 followed by a unit qualifier and the quantity

Package 00904-6615-61. 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 treatm…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078979

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

FDA NDC Directory listings under ANDA 078979
ProductStrengthForm · routeLabelerProduct NDC
Divalproex sodiumDivalproex sodium 125 mg/1Capsule, Delayed releaseOralNorthStar Rx LLC72603-260
Divalproex sodiumDivalproex sodium 125 mg/1Capsule, Delayed releaseOralCardinal Health 107, LLC55154-3552
Divalproex sodiumDivalproex sodium 125 mg/1CapsuleOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8237
Divalproex sodiumDivalproex sodium 125 mg/1Capsule, Delayed releaseOralDr. Reddy's Laboratories Ltd55111-532

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