Prescription drug · ANDA
zaleplon NDC 63629-3405
Zaleplon 10 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-3405-1 | 6362934050163629340501 | 15 CAPSULE in 1 BOTTLE (63629-3405-1)Marketed from Dec 22, 2021 | |
| 63629-3405-2 | 6362934050263629340502 | 30 CAPSULE in 1 BOTTLE (63629-3405-2)Marketed from Dec 22, 2021 | |
| 63629-3405-3 | 6362934050363629340503 | 60 CAPSULE in 1 BOTTLE (63629-3405-3)Marketed from May 26, 2010 | |
| 63629-3405-4 | 6362934050463629340504 | 90 CAPSULE in 1 BOTTLE (63629-3405-4)Marketed from May 31, 2013 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-3405_b59bfb24-a009-4400-9ba3-c3d8fd08b36aSPL ID b59bfb24-a009-4400-9ba3-c3d8fd08b36aSPL set ID b8032b14-5068-19d5-e063-839ed25d7200RxCUI 313761UNII 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
N463629340501followed by a unit qualifier and the quantityPackage 63629-3405-01. 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 . 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.
About NDC 63629-3405
- What is NDC 63629-3405?
- 63629-3405 is the product NDC for zaleplon, Zaleplon 10 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 4 package NDCs, 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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.
Related NDCs: other zaleplon products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | Bionpharma Inc. | 69452-365 | 69452-0365-20 |
| 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 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0236 | 71335-0236-0171335-0236-0271335-0236-03+2 more |
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 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 | PD-Rx Pharmaceuticals, Inc. | 43063-783 |
| zaleplon | Zaleplon 10 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1564 |
| zaleplon | Zaleplon 10 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7208 |
| zaleplon | Zaleplon 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0236 |