NDC codes

FDA NDC Directory
Product NDC (as listed)55111-530Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0530Add 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
55111-530-0155111053001100 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-530-01)Marketed from Jul 29, 2008
55111-530-0555111053005500 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-530-05)Marketed from Jul 29, 2008
55111-530-305511105303030 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-530-30)Marketed from Jul 29, 2008
55111-530-785511105307810 BLISTER PACK in 1 CARTON (55111-530-78) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (55111-530-79)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 — 250 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
Dr.Reddy's Laboratories LimitedNDC labeler code 55111
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078755
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 55111-530_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

N455111053001 followed by a unit qualifier and the quantity

Package 55111-0530-01. 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 . 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)

About NDC 55111-530

What is NDC 55111-530?
55111-530 is the product NDC for divalproex sodium, Divalproex sodium 250 mg/1 tablet, delayed release, listed with the FDA by Dr.Reddy's Laboratories Limited. It has 4 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?
Dr.Reddy's Laboratories Limited, NDC labeler code 55111. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
divalproex sodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralPreferred Pharmaceuticals Inc.68788-419368788-4193-0368788-4193-0668788-4193-09
divalproex sodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralCoupler LLC67046-168367046-1683-03
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralUnit Dose Solutions, Inc.87441-02887441-0028-01
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralUnit Dose Solutions, Inc.87441-02787441-0027-01
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Extended releaseOralCoupler LLC67046-202167046-2021-03
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-410068788-4100-0368788-4100-0668788-4100-09
Divalproex SodiumDivalproex sodium 250 mg/1Tablet, Film coated, Extended releaseOralSafecor Health, LLC48433-03348433-0033-08
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Film coated, Extended releaseOralSafecor Health, LLC48433-03448433-0034-08
Divalproex SodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralREMEDYREPACK INC.70518-457570518-4575-00
divalproex sodiumDivalproex sodium 250 mg/1Tablet, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-407968788-4079-0368788-4079-0668788-4079-09

All 185 divalproex sodium NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
divalproex sodiumDivalproex sodium 125 mg/1Tablet, Delayed releaseOralDr.Reddy's Laboratories Limited55111-529
divalproex sodiumDivalproex sodium 500 mg/1Tablet, Delayed releaseOralDr.Reddy's Laboratories Limited55111-531

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