Prescription drug · ANDA
Zarontin (Ethosuximide) NDC 0071-2418
Ethosuximide 250 mg/5mL · Solution · Oral · Parke-Davis Div of Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0071-2418-19 | 0007124181900071241819 | 1 BOTTLE, PLASTIC in 1 CARTON (0071-2418-19) / 474 mL in 1 BOTTLE, PLASTICMarketed from Jun 1, 2022 |
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)
- Zarontin
- Generic name (nonproprietary)
- ethosuximide
- Active ingredients
- Ethosuximide — 250 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Parke-Davis Div of Pfizer IncNDC labeler code 0071
- 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 0071-2418_6afa95d3-162a-4fbb-ab47-561f4ee7771aSPL ID 6afa95d3-162a-4fbb-ab47-561f4ee7771aSPL set ID 7bf3e616-45e8-4469-a75d-4d824ce951eaRxCUI 251322, 755357UNII 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
N400071241819followed by a unit qualifier and the quantityPackage 00071-2418-19. 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 Zarontin is indicated for the control of absence (petit mal) epilepsy.
Excerpt only. Read the full label for complete information.
About NDC 0071-2418
- What is NDC 0071-2418?
- 0071-2418 is the product NDC for Zarontin (ethosuximide), Ethosuximide 250 mg/5mL solution, listed with the FDA by Parke-Davis Div of Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zarontin (Ethosuximide).
- What is the active ingredient?
- Ethosuximide.
- Who is the labeler?
- Parke-Davis Div of Pfizer Inc, NDC labeler code 0071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zarontin?
- 1 other product NDC are listed under this name. See all Zarontin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zarontin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zarontinethosuximide | Ethosuximide 250 mg/1 | CapsuleOral | Parke-Davis Div of Pfizer Inc | 0071-0237 | 00071-0237-24 |
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 |
|---|---|---|---|---|
| Ethosuximide | Ethosuximide 250 mg/5mL | SolutionOral | Mylan Pharmaceuticals Inc. | 59762-2350 |