NDC 21695-105

ZALEPLON

Zaleplon

ZALEPLON is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp.. The primary component is Zaleplon.

• Product ID: 21695-105_23bb4390-7825-4b2c-9dd9-48d2ee90bc6c
• NDC: 21695-105
• Product Type: Human Prescription Drug
• Proprietary Name: ZALEPLON
• Generic Name: Zaleplon
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2008-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA020859
• Labeler Name: Rebel Distributors Corp.
• Substance Name: ZALEPLON
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]
• DEA Schedule: CIV
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-105-60

60 CAPSULE in 1 BOTTLE, PLASTIC (21695-105-60)

• Marketing Start Date: 2008-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-105-14 [21695010514]

ZALEPLON CAPSULE

• Marketing Category: NDA
• Application Number: NDA020859
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-01
• Inactivation Date: 2019-09-24

NDC 21695-105-30 [21695010530]

ZALEPLON CAPSULE

• Marketing Category: NDA
• Application Number: NDA020859
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-01
• Inactivation Date: 2019-09-24

NDC 21695-105-60 [21695010560]

ZALEPLON CAPSULE

• Marketing Category: NDA
• Application Number: NDA020859
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-01
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
ZALEPLON	10 mg/1

OpenFDA Data

• SPL SET ID: bc7639e9-c2cb-47bb-a295-efb0f656ccd1
• Manufacturer:
  • Rebel Distributors Corp.
• UNII:
  • S62U433RMH
• RxNorm Concept Unique ID - RxCUI:
  • 313762
  • 313761

Pharmacological Class

• gamma-Aminobutyric Acid A Receptor Agonist [EPC]
• GABA A Agonists [MoA]
• Central Nervous System Depression [PE]

NDC Crossover Matching brand name "ZALEPLON" or generic name "Zaleplon"

NDC	Brand Name	Generic Name
0054-0084	Zaleplon	Zaleplon
0054-0085	Zaleplon	Zaleplon
0093-5268	Zaleplon	Zaleplon
0093-5269	Zaleplon	Zaleplon
21695-105	ZALEPLON	ZALEPLON
21695-376	ZALEPLON	ZALEPLON
29300-131	zaleplon	zaleplon
29300-132	zaleplon	zaleplon
33261-454	zaleplon	zaleplon
33261-486	zaleplon	zaleplon
35356-656	zaleplon	zaleplon
42043-210	Zaleplon	Zaleplon
42043-211	Zaleplon	Zaleplon
42254-130	zaleplon	zaleplon
42254-147	zaleplon	zaleplon
42254-189	zaleplon	zaleplon
43063-505	ZALEPLON	ZALEPLON
43063-783	zaleplon	zaleplon
43063-912	Zaleplon	Zaleplon
67877-210	ZALEPLON	ZALEPLON
67877-211	ZALEPLON	ZALEPLON
68788-6850	zaleplon	zaleplon
68788-7208	zaleplon	zaleplon
71335-0236	zaleplon	zaleplon
71335-1054	ZALEPLON	ZALEPLON
45865-541	zaleplon	zaleplon
50090-1564	zaleplon	zaleplon
50090-3420	Zaleplon	Zaleplon
50436-1006	Zaleplon	Zaleplon
52959-957	ZALEPLON	ZALEPLON
55700-190	Zaleplon	Zaleplon
57237-239	ZALEPLON	ZALEPLON
57237-240	ZALEPLON	ZALEPLON
61919-629	ZALEPLON	ZALEPLON
63629-3405	zaleplon	zaleplon
65862-214	ZALEPLON	ZALEPLON
65862-215	ZALEPLON	ZALEPLON
66336-056	Zaleplon	Zaleplon