What is NDC 69452-365?

69452-365 is the product NDC for Zaleplon, Zaleplon 10 mg/1 capsule, listed with the FDA by Bionpharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Bionpharma Inc., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zaleplon?

18 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Zaleplon NDC 69452-365 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-365Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0365Add 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
69452-365-20	6945203652069452036520	100 CAPSULE in 1 BOTTLE (69452-365-20)Marketed from Feb 17, 2024

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: Bionpharma Inc.NDC labeler code 69452
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090374
Marketing start: Feb 17, 2024
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Central Nervous System Depression (Physiologic effect)GABA A Agonists (Mechanism)
Identifiers: Product ID 69452-365_d0929d4c-0f84-40a4-94dc-6f80934e0edfSPL ID d0929d4c-0f84-40a4-94dc-6f80934e0edfSPL set ID 53103d2f-4453-49a8-9e36-888d919879f6RxCUI 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

N469452036520 followed by a unit qualifier and the quantity

Package 69452-0365-20. 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 Feb 13, 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 ). 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.

Full label on DailyMed (opens in a new tab)

About NDC 69452-365

What is NDC 69452-365?: 69452-365 is the product NDC for Zaleplon, Zaleplon 10 mg/1 capsule, listed with the FDA by Bionpharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zaleplon.
What is the active ingredient?: Zaleplon.
Who is the labeler?: Bionpharma Inc., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zaleplon?: 18 other product NDCs are listed under this name. See all Zaleplon NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Zaleplon NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Zaleplon	Zaleplon 10 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8725	68788-8725-0168788-8725-0268788-8725-03+2 more
Zaleplon	Zaleplon 5 mg/1	CapsuleOral	Bionpharma Inc.	69452-364	69452-0364-20
Zaleplon	Zaleplon 10 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2468	71335-2468-0171335-2468-0271335-2468-03+1 more
zaleplon	Zaleplon 10 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-7208	68788-7208-0168788-7208-0268788-7208-03+2 more
zaleplon	Zaleplon 5 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-131	29300-0131-0129300-0131-0529300-0131-13
zaleplon	Zaleplon 10 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-132	29300-0132-0129300-0132-0529300-0132-10
zaleplon	Zaleplon 10 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	43063-783	43063-0783-10
zaleplon	Zaleplon 10 mg/1	CapsuleOral	A-S Medication Solutions	50090-1564	50090-1564-0050090-1564-01
zaleplon	Zaleplon 10 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-3405	63629-3405-0163629-3405-0263629-3405-03+1 more
zaleplon	Zaleplon 5 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0236	71335-0236-0171335-0236-0271335-0236-03+2 more

All 19 Zaleplon NDCs

Other NDCs under ANDA 090374

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

FDA NDC Directory listings under ANDA 090374
Product	Strength	Form · route	Labeler	Product NDC
Zaleplon	Zaleplon 10 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8725
Zaleplon	Zaleplon 5 mg/1	CapsuleOral	Bionpharma Inc.	69452-364
Zaleplon	Zaleplon 10 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2468