Prescription drug · ANDA
Divalproex Sodium NDC 0378-0473
Divalproex sodium 500 mg/1 · Tablet, Film coated, Extended release · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-0473-01 | 0037804730100378047301 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-01)Marketed from Feb 2, 2009 | |
| 0378-0473-05 | 0037804730500378047305 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-05)Marketed from Feb 2, 2009 |
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, Film coated, Extended release
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077567
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0378-0473_4b2ac508-5c61-48e5-8818-45ed3b481f32SPL ID 4b2ac508-5c61-48e5-8818-45ed3b481f32
- 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
N400378047301followed by a unit qualifier and the quantityPackage 00378-0473-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0378-0473
- What is NDC 0378-0473?
- 0378-0473 is the product NDC for Divalproex Sodium, Divalproex sodium 500 mg/1 tablet, film coated, extended release, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 077567
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, Film coated, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-0472 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Film coated, Extended releaseOral | Safecor Health, LLC | 48433-033 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Safecor Health, LLC | 48433-034 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Film coated, Extended releaseOral | Mylan Institutional Inc. | 51079-766 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Mylan Institutional Inc. | 51079-767 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-030 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-707 |