Zaleplon NDC 65862-215

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-215Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0215Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65862-215-01	65862021501	100 CAPSULE in 1 BOTTLE (65862-215-01)Marketed from Jun 6, 2008
65862-215-05	65862021505	500 CAPSULE in 1 BOTTLE (65862-215-05)Marketed from Jun 6, 2008

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: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078829
Marketing start: Jun 6, 2008
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Central Nervous System Depression (Physiologic effect)GABA A Agonists (Mechanism)
Identifiers: Product ID 65862-215_36ab371f-c2fe-4c1d-ad60-801b8f118f4eSPL ID 36ab371f-c2fe-4c1d-ad60-801b8f118f4eSPL set ID e092f3ca-bf44-4568-a72c-3fb2cf5b192bRxCUI 313761, 313762UNII S62U433RMH
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

N465862021501 followed by a unit qualifier and the quantity

Package 65862-0215-01. 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 May 8, 2024. 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 ). They have 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078829

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078829
Product	Strength	Form · route	Labeler	Product NDC
Zaleplon	Zaleplon 5 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	57237-239
Zaleplon	Zaleplon 10 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	57237-240
Zaleplon	Zaleplon 5 mg/1	CapsuleOral	Aurobindo Pharma Limited	65862-214
Zaleplon	Zaleplon 10 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1054
Zaleplon	Zaleplon 5 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	43063-505