What is NDC 46708-821?

46708-821 is the product NDC for Divalproex sodium, Divalproex sodium 125 mg/1 capsule, delayed release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?

184 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 46708-821 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-821Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0821Add 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
46708-821-10	46708082110	100 BLISTER PACK in 1 CARTON (46708-821-10) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Dec 23, 2024
46708-821-31	46708082131	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-821-31)Marketed from Dec 23, 2024
46708-821-91	46708082191	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-821-91)Marketed from Dec 23, 2024

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 — 125 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218793
Marketing start: Dec 23, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 46708-821_f34c4504-5409-406e-995b-138e5f700242SPL ID f34c4504-5409-406e-995b-138e5f700242SPL set ID f34c4504-5409-406e-995b-138e5f700242RxCUI 1099596UNII 644VL95AO6UPC 0346708821319
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

N446708082110 followed by a unit qualifier and the quantity

Package 46708-0821-10. 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 Jan 6, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Divalproex sodium delayed-release capsules are an anti-epileptic drug indicated for: • 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 ) 1.1 Epilepsy Divalproex sodium delayed-release capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release capsules are also indicated for use as sole and adjunctive therapy in the tre…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-821

What is NDC 46708-821?: 46708-821 is the product NDC for Divalproex sodium, Divalproex sodium 125 mg/1 capsule, delayed release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?: 184 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 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
divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-4079	68788-4079-0368788-4079-0668788-4079-09
Divalproex Sodium	Divalproex sodium 500 mg/1	Tablet, Delayed releaseOral	REMEDYREPACK INC.	70518-4575	70518-4575-00

All 185 Divalproex sodium NDCs

Other NDCs under ANDA 218793

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

FDA NDC Directory listings under ANDA 218793
Product	Strength	Form · route	Labeler	Product NDC
Divalproex sodium	Divalproex sodium 125 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-821