ZALEPLON
- Product NDC
- 21695-105
- 11-digit product format
- 216950105
- Labeler code
- 21695
- Product ID
- 21695-105_23bb4390-7825-4b2c-9dd9-48d2ee90bc6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ZALEPLON
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- NDA020859
- Marketing category
- NDA
- Marketing start
- 2008-05-01
- Marketing end
- 0000-00-00
- Substance
- ZALEPLON
- Active strength
- 10 mg/1
- Pharmacologic 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
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 11ca9bc5-afb0-a2d5-938a-c2d33f89f4ab | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-105-14 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b0f-48b1-e053-8cdaa90a720a | Zaleplon Capsules 5 mg and 10 mg CIV Rx only |
| 21695-105-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b0f-48b1-e053-8cdaa90a720a | Zaleplon Capsules 5 mg and 10 mg CIV Rx only |
| 21695-105-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b0f-48b1-e053-8cdaa90a720a | Zaleplon Capsules 5 mg and 10 mg CIV Rx only |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-105-14 | EA - Each | 21695-105 | 76a8c712-3fb5-4e6f-ae45-1f769774c5a3 | 1 | 2012-07-24 |
| 21695-105-30 | EA - Each | 21695-105 | 0f585a66-dc99-4518-8c0e-9dac6fb85a84 | 1 | 2012-07-24 |
| 21695-105-60 | EA - Each | 21695-105 | e3aad828-2928-434d-b631-8fe41f401384 | 1 | 2012-07-24 |