zaleplon
- Product NDC
- 63629-3405
- 11-digit product format
- 636293405
- Labeler code
- 63629
- Product ID
- 63629-3405_b59bfb24-a009-4400-9ba3-c3d8fd08b36a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zaleplon
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078989
- Marketing category
- ANDA
- Marketing start
- 2009-05-05
- Substance
- ZALEPLON
- Active strength
- 10 mg/1
- Pharmacologic classes
- Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- zaleplon
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZALEPLON | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S62U433RMH |
| Rxcui | 313761 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-3405-1 | zaleplon | 15 in 1 BOTTLE | CAPSULE | 15 | | 8 |
| 63629-3405-2 | zaleplon | 30 in 1 BOTTLE | CAPSULE | 30 | | 8 |
| 63629-3405-3 | zaleplon | 60 in 1 BOTTLE | CAPSULE | 60 | | 8 |
| 63629-3405-4 | zaleplon | 90 in 1 BOTTLE | CAPSULE | 90 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-3405 | ZALEPLON CAPSULE [BRYANT RANCH PREPACK] | 8 | Current NDC, Legacy NDC, 4 package rows | 20231101_b8032b14-5068-19d5-e063-839ed25d7200.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-3405-1 | 63629340501 | 15 CAPSULE in 1 BOTTLE (63629-3405-1) | 15 capsule | 2021-12-22 | 0000-00-00 | No | No | Current |
| 63629-3405-2 | 63629340502 | 30 CAPSULE in 1 BOTTLE (63629-3405-2) | 30 capsule | 2021-12-22 | 0000-00-00 | No | No | Current |
| 63629-3405-3 | 63629340503 | 60 CAPSULE in 1 BOTTLE (63629-3405-3) | 60 capsule | 2010-05-26 | 0000-00-00 | No | No | Current |
| 63629-3405-4 | 63629340504 | 90 CAPSULE in 1 BOTTLE (63629-3405-4) | 90 capsule | 2013-05-31 | 0000-00-00 | No | No | Current |