Prescription drug · ANDA
Levetiracetam Levetiracetam (Levetiracetam) NDC 17856-0574
Levetiracetam 100 mg/mL · Solution · Oral · Atlantic Biologicals Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0574-1 | 1785605740117856057401 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0574-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0574-2)Marketed from Aug 25, 2021 |
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)
- Levetiracetam LevetiracetamSuffix: Levetiracetam
- Generic name (nonproprietary)
- levetiracetam
- Active ingredients
- Levetiracetam — 100 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Atlantic Biologicals Corp.NDC labeler code 17856
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203052
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 17856-0574_579e0b39-a063-e168-e063-6294a90aef60SPL ID 579e0b39-a063-e168-e063-6294a90aef60SPL set ID 56fed03f-38c3-4273-8fd7-522bc508bf36RxCUI 403884UNII 44YRR34555
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
N417856057401followed by a unit qualifier and the quantityPackage 17856-0574-01. 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 .
Indications (excerpt from the label)
Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: • Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) • Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) 1.1 Partial-Onset Seizures Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam oral solution is indicated as ad…
Excerpt only. Read the full label for complete information.
About NDC 17856-0574
- What is NDC 17856-0574?
- 17856-0574 is the product NDC for Levetiracetam Levetiracetam (levetiracetam), Levetiracetam 100 mg/mL solution, listed with the FDA by Atlantic Biologicals Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levetiracetam Levetiracetam (Levetiracetam).
- What is the active ingredient?
- Levetiracetam.
- Who is the labeler?
- Atlantic Biologicals Corp., NDC labeler code 17856. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levetiracetam Levetiracetam?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 203052
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 |
|---|---|---|---|---|
| Levetiracetamlevetiracetam oral | Levetiracetam 100 mg/mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-574 |
| Levetiracetam | Levetiracetam 100 mg/mL | SolutionOral | American Health Packaging | 60687-249 |
| Levetiracetam | Levetiracetam 100 mg/mL | SolutionOral | Natco Pharma USA LLC | 69339-157 |