Prescription drug · NDA
Depakote ER (Divalproex sodium) NDC 0074-7401
Divalproex sodium 250 mg/1 · Tablet, Extended release · Oral · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-7401-13 | 0007474011300074740113 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-7401-13)Marketed from Aug 4, 2000 |
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)
- Depakote ERSuffix: ER
- Generic name (nonproprietary)
- divalproex sodium
- Active ingredients
- Divalproex sodium — 250 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021168
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0074-7401_0ee65b66-ead3-44ef-911f-14965b067903SPL ID 0ee65b66-ead3-44ef-911f-14965b067903SPL set ID 0dc024ce-efc8-4690-7cb5-639c728fccacRxCUI 1099563, 1099565, 1099569, 1099571UNII 644VL95AO6UPC 0300747402137, 0300747401130
- 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
N400074740113followed by a unit qualifier and the quantityPackage 00074-7401-13. 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)
Depakote ER is indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features ( 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 Depakote ER is a valproate and is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mani…
Excerpt only. Read the full label for complete information.
About NDC 0074-7401
- What is NDC 0074-7401?
- 0074-7401 is the product NDC for Depakote ER (divalproex sodium), Divalproex sodium 250 mg/1 tablet, extended release, listed with the FDA by AbbVie Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Depakote ER (Divalproex Sodium).
- What is the active ingredient?
- Divalproex sodium.
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Depakote ER?
- 1 other product NDC are listed under this name. See all Depakote ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Depakote ER products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Depakote ERdivalproex sodium | Divalproex sodium 500 mg/1 | Tablet, Extended releaseOral | AbbVie Inc. | 0074-7402 | 00074-7402-13 |
Other NDCs under NDA 021168
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 |
|---|---|---|---|---|
| Depakote ERdivalproex sodium | Divalproex sodium 500 mg/1 | Tablet, Extended releaseOral | AbbVie Inc. | 0074-7402 |