NDC codes

FDA NDC Directory
Product NDC (as listed)17856-0574Labeler and product segments. Claims need a package NDC.
Product NDC at billing width17856-0574Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
17856-0574-1178560574011785605740172 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

N417856057401 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under ANDA 203052
ProductStrengthForm · routeLabelerProduct NDC
Levetiracetamlevetiracetam oralLevetiracetam 100 mg/mLSolutionOralCamber Pharmaceuticals, Inc.31722-574
LevetiracetamLevetiracetam 100 mg/mLSolutionOralAmerican Health Packaging60687-249
LevetiracetamLevetiracetam 100 mg/mLSolutionOralNatco Pharma USA LLC69339-157

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