Prescription drug · ANDA
Ethosuximide NDC 59762-2350
Ethosuximide 250 mg/5mL · Solution · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-2350-6 | 5976223500659762235006 | 1 BOTTLE, PLASTIC in 1 CARTON (59762-2350-6) / 474 mL in 1 BOTTLE, PLASTICMarketed from Feb 21, 2020 | |
| 59762-2350-7 | 5976223500759762235007 | 1 BOTTLE, PLASTIC in 1 CARTON (59762-2350-7) / 474 mL in 1 BOTTLE, PLASTICMarketed from Jul 1, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 59762
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080258
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 59762-2350_04f63742-92af-4b78-a7a6-f9f2f1c269e7SPL ID 04f63742-92af-4b78-a7a6-f9f2f1c269e7SPL set ID 19c924c2-f558-4c78-9277-2d7e0df2f505RxCUI 251322UNII 5SEH9X1D1D
- 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
N459762235006followed by a unit qualifier and the quantityPackage 59762-2350-06. 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 is indicated for the control of absence (petit mal) epilepsy.
Excerpt only. Read the full label for complete information.
About NDC 59762-2350
- What is NDC 59762-2350?
- 59762-2350 is the product NDC for Ethosuximide, Ethosuximide 250 mg/5mL solution, 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?
- Ethosuximide.
- What is the active ingredient?
- Ethosuximide.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 59762. 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/1 | CapsuleOral | Strides Pharma Science Limited | 64380-878 | 64380-0878-06 |
| 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 |
Other NDCs under ANDA 080258
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 |
|---|---|---|---|---|
| Zarontinethosuximide | Ethosuximide 250 mg/5mL | SolutionOral | Parke-Davis Div of Pfizer Inc | 0071-2418 |