What is NDC 72189-459?

72189-459 is the product NDC for Divalproex Sodium ER, Divalproex sodium 500 mg/1 tablet, extended release, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Divalproex Sodium ER?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Divalproex Sodium ER NDC 72189-459

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-459Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0459Add 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 NDC	11-digit (billing)	Package	Copy
72189-459-60	7218904596072189045960	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-459-60)Marketed from Apr 3, 2023

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 ER
Generic name (nonproprietary): divalproex sodium er
Active ingredients: Divalproex sodium — 500 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209286
Marketing start: Apr 3, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 72189-459_2c4dbb36-4841-f211-e063-6294a90ad364SPL ID 2c4dbb36-4841-f211-e063-6294a90ad364SPL set ID f86f185b-4acb-43b5-e053-6394a90a681cRxCUI 1099569UNII 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

N472189045960 followed by a unit qualifier and the quantity

Package 72189-0459-60. 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 Jan 22, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

1.1 Mania Divalproex sodium extended-release tablets are 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 elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). The…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-459

What is NDC 72189-459?: 72189-459 is the product NDC for Divalproex Sodium ER, Divalproex sodium 500 mg/1 tablet, extended release, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Divalproex Sodium ER.
What is the active ingredient?: Divalproex sodium.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Divalproex Sodium ER?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 209286

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

FDA NDC Directory listings under ANDA 209286
Product	Strength	Form · route	Labeler	Product NDC
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Extended releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8376
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8377
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-260
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-261
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	Preferred Pharmaceuticals, Inc.	68788-8358
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-3183
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-3477
Divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-1883
Divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-286