Prescription drug · ANDA
Ethosuximide NDC 64380-878
Ethosuximide 250 mg/1 · Capsule · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-878-06 | 6438008780664380087806 | 100 CAPSULE in 1 BOTTLE (64380-878-06)Marketed from May 15, 2019 |
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)
- Ethosuximide
- Generic name (nonproprietary)
- ethosuximide
- Active ingredients
- Ethosuximide — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211928
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 64380-878_55122228-722f-dcba-e063-6394a90ab78aSPL ID 55122228-722f-dcba-e063-6394a90ab78aSPL set ID a4dbc665-4db1-4d0a-9630-5cd200ec4c82RxCUI 197682UNII 5SEH9X1D1DUPC 0364380878063
- Pharmacologic class
- Anti-epileptic Agent
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
N464380087806followed by a unit qualifier and the quantityPackage 64380-0878-06. 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)
INDICATIONS AND USAGE Ethosuximide capsule is indicated for the control of absence (petit mal) epilepsy.
Excerpt only. Read the full label for complete information.
About NDC 64380-878
- What is NDC 64380-878?
- 64380-878 is the product NDC for Ethosuximide, Ethosuximide 250 mg/1 capsule, listed with the FDA by Strides Pharma Science Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ethosuximide.
- What is the active ingredient?
- Ethosuximide.
- Who is the labeler?
- Strides Pharma Science Limited, NDC labeler code 64380. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ethosuximide?
- 9 other product NDCs are listed under this name. See all Ethosuximide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ethosuximide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ethosuximide | Ethosuximide 250 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-708 | 42806-0708-01 |
| Ethosuximide | Ethosuximide 250 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-711 | 42806-0711-01 |
| Ethosuximide | Ethosuximide 250 mg/5mL | SolutionOral | Mylan Pharmaceuticals Inc. | 59762-2350 | 59762-2350-0659762-2350-07 |
| Ethosuximide | Ethosuximide 250 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 63629-8005 | 63629-8005-01 |
| Ethosuximide | Ethosuximide 250 mg/1 | Capsule, Liquid filledOral | Bionpharma Inc. | 69452-152 | 69452-0152-20 |
| Ethosuximide | Ethosuximide 250 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-790 | 62135-0790-12 |
| Ethosuximide | Ethosuximide 250 mg/5mL | SolutionOral | Chartwell RX, LLC | 62135-064 | 62135-0064-47 |
| Ethosuximide | Ethosuximide 250 mg/5mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-064 | 68999-0064-24 |
| Ethosuximide | Ethosuximide 250 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0670 | 00121-0670-16 |