NDC codes

FDA NDC Directory
Product NDC (as listed)65162-755Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65162-0755Add 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
65162-755-1065162075510100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-755-10)Marketed from Jun 1, 2015
65162-755-5065162075550500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-755-50)Marketed from Jun 1, 2015

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 — 250 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203730
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 65162-755_5284ecb4-6f0a-4388-8f78-a48e0c0123d6SPL ID 5284ecb4-6f0a-4388-8f78-a48e0c0123d6SPL set ID 7d3352ee-a240-43ff-a243-29ad2bc989c7RxCUI 1099563, 1099569UNII 644VL95AO6UPC 0365162755107, 0365162757101
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

N465162075510 followed by a unit qualifier and the quantity

Package 65162-0755-10. 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 extended-release tablets are indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (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 extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally and persistently e…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203730

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

FDA NDC Directory listings under ANDA 203730
ProductStrengthForm · routeLabelerProduct NDC
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-2036
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Extended releaseOralAmneal Pharmaceuticals LLC65162-757
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Extended releaseOralMajor Pharmaceuticals0904-7182
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-1556
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Extended releaseOralAvPAK50268-259
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Extended releaseOralAvPAK50268-260
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Extended releaseOralCardinal Health 107, LLC55154-2345

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