Zaleplon
- Product NDC
- 71335-2468
- 11-digit product format
- 713352468
- Labeler code
- 71335
- Product ID
- 71335-2468_5cbad0f1-c66b-4bd0-bfb0-530333c5e4d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zaleplon
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090374
- Marketing category
- ANDA
- Marketing start
- 2024-02-17
- 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 |
|---|
| 71335-2468-1 | Zaleplon | 15 in 1 BOTTLE | CAPSULE | 15 | | 2 |
| 71335-2468-2 | Zaleplon | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
| 71335-2468-3 | Zaleplon | 60 in 1 BOTTLE | CAPSULE | 60 | | 2 |
| 71335-2468-4 | Zaleplon | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2468 | ZALEPLON CAPSULE [BRYANT RANCH PREPACK] | 2 | Current NDC, 4 package rows | 20240817_517953c8-22ad-41af-a869-b7e4e5b291ae.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2468-1 | 71335246801 | 15 CAPSULE in 1 BOTTLE (71335-2468-1) | 15 capsule | 2024-08-16 | No | No | Current |
| 71335-2468-2 | 71335246802 | 30 CAPSULE in 1 BOTTLE (71335-2468-2) | 30 capsule | 2024-08-16 | No | No | Current |
| 71335-2468-3 | 71335246803 | 60 CAPSULE in 1 BOTTLE (71335-2468-3) | 60 capsule | 2024-08-16 | No | No | Current |
| 71335-2468-4 | 71335246804 | 90 CAPSULE in 1 BOTTLE (71335-2468-4) | 90 capsule | 2024-08-16 | No | No | Current |