NDC codes

FDA NDC Directory
Product NDC (as listed)55154-5633Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-5633Add 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
55154-5633-05515456330010 BLISTER PACK in 1 BAG (55154-5633-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Apr 1, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078182
Marketing start
Marketing end
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 55154-5633_c8d211c4-2617-4f33-b0fd-f1deda2a939cSPL ID c8d211c4-2617-4f33-b0fd-f1deda2a939cSPL set ID 4fc50afb-67f3-4bf3-9ec3-cc12734f47fdRxCUI 1099870UNII 644VL95AO6UPC 0055154563307
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

N455154563300 followed by a unit qualifier and the quantity

Package 55154-5633-00. 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

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Divalproex sodium delayed-release tablets are an anti-epileptic drug indicated for: • Treatment of manic episodes associated with bipolar disorder ( 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 is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, mo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078182

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

FDA NDC Directory listings under ANDA 078182
ProductStrengthForm · routeLabelerProduct NDC
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-031
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-032
Divalproex SodiumDivalproex sodium 125 mg/1Tablet, Delayed releaseOralUpsher-Smith Laboratories, LLC0832-7122
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralUpsher-Smith Laboratories, LLC0832-7123
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralUpsher-Smith Laboratories, LLC0832-7124

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