zaleplon
- Product NDC
- 43063-783
- 11-digit product format
- 430630783
- Labeler code
- 43063
- Product ID
- 43063-783_414baf08-dc02-c431-e063-6394a90ae4ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zaleplon
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-783-10 | zaleplon | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-783 | ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 16 | Current NDC, Legacy NDC, 1 package rows | 20241017_2cc7adee-2c4c-4fed-9914-545e70dba773.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 |
|---|
| 43063-783-10 | 43063078310 | 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-783-10) | 10 capsule | 2017-08-24 | 0000-00-00 | No | No | Current |