Prescription drug · NDA
Spritam (Levetiracetam) NDC 43485-101
Levetiracetam 250 mg/1 · Tablet, For suspension · Oral · Aprecia Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43485-101-03 | 43485010103 | 6 BLISTER PACK in 1 CARTON (43485-101-03) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-101-01)Marketed from Jan 31, 2026 | |
| 43485-101-60 | 43485010160 | 60 BLISTER PACK in 1 CARTON (43485-101-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-101-01)Marketed from Feb 5, 2016 |
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)
- Spritam
- Generic name (nonproprietary)
- levetiracetam
- Active ingredients
- Levetiracetam — 250 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Labeler
- Aprecia Pharmaceuticals, LLCNDC labeler code 43485
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207958
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 43485-101_890ef534-7363-4f2b-b125-8f62e2eb26d0SPL ID 890ef534-7363-4f2b-b125-8f62e2eb26d0SPL set ID be651c31-383f-11e4-916c-0800200c9a66RxCUI 1736037, 1736044, 1736045, 1736047, 1736048, 1736050, 1736051, 1736053UNII 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
N443485010103followed by a unit qualifier and the quantityPackage 43485-0101-03. 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)
SPRITAM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg ( 1.1 ) SPRITAM 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 SPRITAM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy SPRITAM is indicated as adjunctive therapy for the tre…
Excerpt only. Read the full label for complete information.
About NDC 43485-101
- What is NDC 43485-101?
- 43485-101 is the product NDC for Spritam (levetiracetam), Levetiracetam 250 mg/1 tablet, for suspension, listed with the FDA by Aprecia Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Spritam (Levetiracetam).
- What is the active ingredient?
- Levetiracetam.
- Who is the labeler?
- Aprecia Pharmaceuticals, LLC, NDC labeler code 43485. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Spritam?
- 3 other product NDCs are listed under this name. See all Spritam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Spritam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Spritamlevetiracetam | Levetiracetam 500 mg/1 | Tablet, For suspensionOral | Aprecia Pharmaceuticals, LLC | 43485-102 | 43485-0102-0343485-0102-60 |
| Spritamlevetiracetam | Levetiracetam 750 mg/1 | Tablet, For suspensionOral | Aprecia Pharmaceuticals, LLC | 43485-103 | 43485-0103-60 |
| Spritamlevetiracetam | Levetiracetam 1000 mg/1 | Tablet, For suspensionOral | Aprecia Pharmaceuticals, LLC | 43485-104 | 43485-0104-60 |
Other NDCs under NDA 207958
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 |
|---|---|---|---|---|
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, For suspensionOral | Prasco Laboratories | 66993-100 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, For suspensionOral | Prasco Laboratories | 66993-101 |
| Spritamlevetiracetam | Levetiracetam 500 mg/1 | Tablet, For suspensionOral | Aprecia Pharmaceuticals, LLC | 43485-102 |
| Spritamlevetiracetam | Levetiracetam 750 mg/1 | Tablet, For suspensionOral | Aprecia Pharmaceuticals, LLC | 43485-103 |
| Spritamlevetiracetam | Levetiracetam 1000 mg/1 | Tablet, For suspensionOral | Aprecia Pharmaceuticals, LLC | 43485-104 |