Prescription drug · ANDA
zaleplon NDC 43063-783
Zaleplon 10 mg/1 · Capsule · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-783-10 | 43063078310 | 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-783-10)Marketed from Aug 24, 2017 |
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)
- zaleplon
- Generic name (nonproprietary)
- zaleplon
- Active ingredients
- Zaleplon — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078989
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)GABA A Agonists (Mechanism)
- Identifiers
- Product ID 43063-783_414baf08-dc02-c431-e063-6394a90ae4eeSPL ID 414baf08-dc02-c431-e063-6394a90ae4eeSPL set ID 2cc7adee-2c4c-4fed-9914-545e70dba773RxCUI 313761UNII S62U433RMHUPC 0343063783108
- 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
N443063078310followed by a unit qualifier and the quantityPackage 43063-0783-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Zaleplon capsules are indicated for the short-term treatment of insomnia. Zaleplon capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078989
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 |
|---|---|---|---|---|
| zaleplon | Zaleplon 10 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1564 |
| zaleplon | Zaleplon 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0236 |
| zaleplon | Zaleplon 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-3405 |
| zaleplon | Zaleplon 5 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-131 |
| zaleplon | Zaleplon 10 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-132 |
| zaleplon | Zaleplon 10 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7208 |