Prescription drug · ANDA
Divalproex Sodium NDC 61919-249
Divalproex sodium 500 mg/1 · Tablet, Delayed release · Oral · DirectRx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-249-30 | 6191902493061919024930 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-249-30)Marketed from Apr 6, 2022 | |
| 61919-249-60 | 6191902496061919024960 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-249-60)Marketed from Apr 6, 2022 |
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 — 500 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- DirectRxNDC labeler code 61919
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079163
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 61919-249_4d3b1fe0-aac6-600d-e063-6394a90a4a87SPL ID 4d3b1fe0-aac6-600d-e063-6394a90a4a87SPL set ID ce12c7b1-caa9-4224-bb5f-3e20e0281d66RxCUI 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
N461919024930followed by a unit qualifier and the quantityPackage 61919-0249-30. 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 .
Indications (excerpt from the label)
1.1 Mania Divalproex sodium delayed release tablets are 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 speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. The efficacy of divalproex sodium delayed release tablets was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)]. The safety and effectiveness …
Excerpt only. Read the full label for complete information.
About NDC 61919-249
- What is NDC 61919-249?
- 61919-249 is the product NDC for Divalproex Sodium, Divalproex sodium 500 mg/1 tablet, delayed release, listed with the FDA by DirectRx. It has 2 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?
- DirectRx, NDC labeler code 61919. 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.
Related NDCs: other Divalproex Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 079163
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-4575 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Coupler LLC | 67046-0875 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-2626 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-0008 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-138 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-139 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-140 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Northwind Health Company, LLC | 51655-365 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-027 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-028 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-2007 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | BluePoint Laboratories | 68001-472 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-857 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | BluePoint Laboratories | 68001-473 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | BluePoint Laboratories | 68001-474 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-868 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 63629-4278 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-879 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2862 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-4861 |
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