Prescription drug · ANDA
divalproex sodium NDC 65841-639
Divalproex sodium 125 mg/1 · Capsule, Coated pellets · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-639-01 | 6584106390165841063901 | 100 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-639-01)Marketed from Jan 27, 2009 | |
| 65841-639-10 | 6584106391065841063910 | 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-639-10)Marketed from Jan 27, 2009 | |
| 65841-639-30 | 6584106393065841063930 | 10 BLISTER PACK in 1 CARTON (65841-639-30) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACKMarketed from Jan 27, 2009 |
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
- Capsule, Coated pellets
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 65841
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078919
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 65841-639_9b43fd1a-165d-420e-ba4f-f7bfaea4c283SPL ID 9b43fd1a-165d-420e-ba4f-f7bfaea4c283SPL set ID b0f33792-dd96-40cc-a28e-acdcdca2f4b8RxCUI 1099596UNII 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
N465841063901followed by a unit qualifier and the quantityPackage 65841-0639-01. 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 .
About NDC 65841-639
- What is NDC 65841-639?
- 65841-639 is the product NDC for divalproex sodium, Divalproex sodium 125 mg/1 capsule, coated pellets, listed with the FDA by Zydus Lifesciences Limited. It has 3 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?
- Zydus Lifesciences Limited, NDC labeler code 65841. 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 078919
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 125 mg/1 | Capsule, Coated pelletsOral | ATLANTIC BIOLOGICALS CORP. | 17856-0109 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Capsule, Coated pelletsOral | Cardinal Health 107, LLC | 55154-4759 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Capsule, Coated pelletsOral | American Health Packaging | 68084-313 |
| divalproex sodium | Divalproex sodium 125 mg/1 | Capsule, Coated pelletsOral | Zydus Pharmaceuticals USA Inc. | 68382-106 |
| divalproex sodium | Divalproex sodium 125 mg/1 | Capsule, Coated pelletsOral | REMEDYREPACK INC. | 70518-1749 |