NDC codes

FDA NDC Directory
Product NDC (as listed)55111-533Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0533Add 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
55111-533-0155111053301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-533-01)Marketed from Aug 11, 2013
55111-533-0555111053305500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-533-05)Marketed from Aug 11, 2013
55111-533-305511105333030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-533-30)Marketed from Aug 11, 2013
55111-533-605511105336060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-533-60)Marketed from Aug 11, 2013
55111-533-785511105337810 BLISTER PACK in 1 CARTON (55111-533-78) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (55111-533-79)Marketed from Aug 11, 2013

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 sodium250 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090161
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 55111-533_86498fa3-61af-c27e-9f94-b2a3fb6e16dfSPL ID 86498fa3-61af-c27e-9f94-b2a3fb6e16dfSPL set ID 2e35f833-1cf7-12eb-9567-7a191e32e138RxCUI 1099563UNII 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

N455111053301 followed by a unit qualifier and the quantity

Package 55111-0533-01. 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 extended-release tablet is 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 tablet is a valproate and is 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 elevated,

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090161

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

FDA NDC Directory listings under ANDA 090161
ProductStrengthForm · routeLabelerProduct NDC
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-1138
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralMajor Pharmaceuticals0904-6363
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Extended releaseOralCoupler LLC67046-2021

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