Prescription drug · NDA
Spritam (Levetiracetam) NDC 43485-103
Levetiracetam 750 mg/1 · Tablet, For suspension · Oral · Aprecia Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43485-103-60 | 43485010360 | 60 BLISTER PACK in 1 CARTON (43485-103-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-103-01)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 — 750 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
- Marketing end
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 43485-103_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
N443485010360followed by a unit qualifier and the quantityPackage 43485-0103-60. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 43485-103
- What is NDC 43485-103?
- 43485-103 is the product NDC for Spritam (levetiracetam), Levetiracetam 750 mg/1 tablet, for suspension, listed with the FDA by Aprecia Pharmaceuticals, LLC. It has 1 package NDC, 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 250 mg/1 | Tablet, For suspensionOral | Aprecia Pharmaceuticals, LLC | 43485-101 | 43485-0101-0343485-0101-60 |
| Spritamlevetiracetam | Levetiracetam 500 mg/1 | Tablet, For suspensionOral | Aprecia Pharmaceuticals, LLC | 43485-102 | 43485-0102-0343485-0102-60 |
| 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 250 mg/1 | Tablet, For suspensionOral | Aprecia Pharmaceuticals, LLC | 43485-101 |
| Spritamlevetiracetam | Levetiracetam 500 mg/1 | Tablet, For suspensionOral | Aprecia Pharmaceuticals, LLC | 43485-102 |
| Spritamlevetiracetam | Levetiracetam 1000 mg/1 | Tablet, For suspensionOral | Aprecia Pharmaceuticals, LLC | 43485-104 |