ZALEPLON
- Product NDC
- 57237-240
- 11-digit product format
- 572370240
- Labeler code
- 57237
- Product ID
- 57237-240_344d16be-8384-4299-995d-97b48d5d62c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ZALEPLON
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA078829
- Marketing category
- ANDA
- Marketing start
- 2008-06-06
- 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, 313762 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57237-240-01 | ZALEPLON | 100 in 1 BOTTLE | CAPSULE | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57237-240 | ZALEPLON CAPSULE [RISING PHARMA HOLDINGS, INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240515_cff46def-c452-49bb-abea-480de8f432bd.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 |
|---|
| 57237-240-01 | 57237024001 | 100 CAPSULE in 1 BOTTLE (57237-240-01) | 100 capsule | 2008-06-06 | 0000-00-00 | No | No | Current |