Prescription drug · ANDA
Zaleplon NDC 0054-0085
Zaleplon 10 mg/1 · Capsule · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0085-25 | 00054008525 | 100 CAPSULE in 1 BOTTLE (0054-0085-25)Marketed from Jun 6, 2008 |
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)
- Zaleplon
- Generic name (nonproprietary)
- zaleplon
- Active ingredients
- Zaleplon — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077237
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)GABA A Agonists (Mechanism)
- Identifiers
- Product ID 0054-0085_d97e7e61-defc-47f5-aeca-11cecae47e79SPL ID d97e7e61-defc-47f5-aeca-11cecae47e79SPL set ID cadd9d75-2139-4fab-94ce-2992e6a55780RxCUI 313761, 313762UNII S62U433RMHUPC 0300540085254, 0300540084257
- Pharmacologic class
- gamma-Aminobutyric Acid A Receptor Agonist
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
N400054008525followed by a unit qualifier and the quantityPackage 00054-0085-25. 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.
Other NDCs under ANDA 077237
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.