divalproex sodium NDC 55111-529

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-529Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0529Add 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
55111-529-01	55111052901	100 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-529-01)Marketed from Jul 29, 2008
55111-529-05	55111052905	500 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-529-05)Marketed from Jul 29, 2008
55111-529-30	55111052930	30 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-529-30)Marketed from Jul 29, 2008
55111-529-78	55111052978	10 BLISTER PACK in 1 CARTON (55111-529-78) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (55111-529-79)Marketed from Jul 29, 2008

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: Tablet, Delayed release
Route: Oral
Labeler: Dr.Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078755
Marketing start: Jul 29, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 55111-529_be502229-0e61-8481-dda9-794c93637dd7SPL ID be502229-0e61-8481-dda9-794c93637dd7SPL set ID 15f8a5be-e269-2e07-60d9-1dd7bf5f5281RxCUI 1099625, 1099678, 1099870UNII 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

N455111052901 followed by a unit qualifier and the quantity

Package 55111-0529-01. 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 Dec 6, 2018. This label includes a boxed warning.

Indications (excerpt from the label)

Divalproex sodium delayed-release tablet 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 tablet is a 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 s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078755

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

FDA NDC Directory listings under ANDA 078755
Product	Strength	Form · route	Labeler	Product NDC
divalproex sodium	Divalproex sodium 500 mg/1	Tablet, Delayed releaseOral	Dr.Reddy's Laboratories Limited	55111-531
divalproex sodium	Divalproex sodium 250 mg/1	Tablet, Delayed releaseOral	Dr.Reddy's Laboratories Limited	55111-530