Prescription drug · ANDA
Divalproex Sodium NDC 0904-7182
Divalproex sodium 500 mg/1 · Tablet, Extended release · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7182-45 | 0090471824500904718245 | 80 BLISTER PACK in 1 CARTON (0904-7182-45) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 1, 2015 | |
| 0904-7182-61 | 0090471826100904718261 | 100 BLISTER PACK in 1 CARTON (0904-7182-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 1, 2015 |
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
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203730
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0904-7182_19acc420-da66-4346-a7fa-9dc17cb623e7SPL ID 19acc420-da66-4346-a7fa-9dc17cb623e7
- 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
N400904718245followed by a unit qualifier and the quantityPackage 00904-7182-45. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0904-7182
- What is NDC 0904-7182?
- 0904-7182 is the product NDC for Divalproex Sodium, Divalproex sodium 500 mg/1 tablet, extended release, listed with the FDA by Major Pharmaceuticals. 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?
- Major Pharmaceuticals, NDC labeler code 0904. 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 203730
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 250 mg/1 | Tablet, Extended releaseOral | AvPAK | 50268-259 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Extended releaseOral | AvPAK | 50268-260 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Extended releaseOral | Cardinal Health 107, LLC | 55154-2345 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-755 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-757 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-1556 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-2036 |