What is NDC 0615-8377?

0615-8377 is the product NDC for Divalproex sodium, Divalproex sodium 500 mg/1 tablet, extended release, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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?

185 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Divalproex sodium NDC 0615-8377 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8377Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8377Add 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
0615-8377-39	0061583773900615837739	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8377-39)Marketed from Feb 3, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 500 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209286
Marketing start: Sep 18, 2020
Marketing end: Oct 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 0615-8377_be5c8101-031d-436c-a3ba-6816e2922bb3SPL ID be5c8101-031d-436c-a3ba-6816e2922bb3SPL set ID 319bbead-bec8-4bb7-9ecb-b2e161c44b8dRxCUI 1099563, 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

N400615837739 followed by a unit qualifier and the quantity

Package 00615-8377-39. 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 Sep 13, 2024. 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 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 ele…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8377

What is NDC 0615-8377?: 0615-8377 is the product NDC for Divalproex sodium, Divalproex sodium 500 mg/1 tablet, extended release, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Divalproex sodium.
What is the active ingredient?: Divalproex sodium.
Who is the labeler?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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?: 185 other product NDCs are listed under this name. See all Divalproex sodium NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Divalproex sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	Coupler LLC	67046-1696	67046-1696-03
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Delayed releaseOral	Cardinal Health 107, LLC	55154-0577	55154-0577-00
divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-4193	68788-4193-0368788-4193-0668788-4193-09
divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Delayed releaseOral	Coupler LLC	67046-1683	67046-1683-03
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Delayed releaseOral	Unit Dose Solutions, Inc.	87441-027	87441-0027-01
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Delayed releaseOral	Unit Dose Solutions, Inc.	87441-028	87441-0028-01
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-2021	67046-2021-03
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-4100	68788-4100-0368788-4100-0668788-4100-09
Divalproex Sodium	Divalproex sodium 250 mg/1	Tablet, Film coated, Extended releaseOral	Safecor Health, LLC	48433-033	48433-0033-08
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Film coated, Extended releaseOral	Safecor Health, LLC	48433-034	48433-0034-08

All 186 Divalproex sodium NDCs

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 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
Divalproex Sodium ER	Divalproex sodium 500 mg/1	Tablet, Extended releaseOral	Direct_Rx	72189-459