Prescription drug · ANDA
Zaleplon NDC 43063-912
Zaleplon 10 mg/1 · Capsule · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-912-10 | 43063091210 | 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-912-10)Marketed from Dec 5, 2018 |
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 077237
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)GABA A Agonists (Mechanism)
- Identifiers
- Product ID 43063-912_415d7fa5-73ac-93e7-e063-6294a90a02a3SPL ID 415d7fa5-73ac-93e7-e063-6294a90a02a3SPL set ID a1277ef5-6072-43ff-a6ce-0a7cea58b7cbRxCUI 313761UNII S62U433RMHUPC 0343063912102
- 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
N443063091210followed by a unit qualifier and the quantityPackage 43063-0912-10. 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 is indicated for the short-term treatment of insomnia. Zaleplon has 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 077237
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.