Prescription drug · ANDA

Divalproex Sodium NDC 50090-2007

Divalproex sodium 250 mg/1 · Tablet, Delayed release · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-2007Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-2007Add 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
50090-2007-05009020070030 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-2007-0)Marketed from Sep 18, 2015
50090-2007-150090200701100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-2007-1)Marketed from Aug 2, 2017

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 — 250 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079163
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 50090-2007_03649250-3fe3-4ea4-beba-11ef72d144ebSPL ID 03649250-3fe3-4ea4-beba-11ef72d144ebSPL set ID 8ecfe765-d743-4308-9cd9-4a7b1a229ea9RxCUI 1099678UNII 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

N450090200700 followed by a unit qualifier and the quantity

Package 50090-2007-00. 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 is 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 delayed-release tablets are 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, motor hype…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079163

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

FDA NDC Directory listings under ANDA 079163
ProductStrengthForm · routeLabelerProduct NDC
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralUnichem Pharmaceuticals (USA), Inc.29300-140
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralUnit Dose Solutions, Inc.87441-028
Divalproex SodiumDivalproex sodium 125 mg/1Tablet, Delayed releaseOralUnichem Pharmaceuticals (USA), Inc.29300-138
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralUnichem Pharmaceuticals (USA), Inc.29300-139
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-2862
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralBluePoint Laboratories68001-473
Divalproex SodiumDivalproex sodium 125 mg/1Tablet, Delayed releaseOralBluePoint Laboratories68001-472
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralBluePoint Laboratories68001-474
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack72162-2460
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-2885
Divalproex SodiumDivalproex sodium 125 mg/1Tablet, Delayed releaseOralAmerican Health Packaging60687-857
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralUnit Dose Solutions, Inc.87441-027
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralAmerican Health Packaging60687-868
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralAmerican Health Packaging60687-879
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-2124
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralProficient Rx LP63187-743
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralProficient Rx LP63187-742
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralDirectRx61919-249
Divalproex SodiumDivalproex sodium 125 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-4861
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-0008

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