Zaleplon
- Product NDC
- 69452-364
- 11-digit product format
- 694520364
- Labeler code
- 69452
- Product ID
- 69452-364_d0929d4c-0f84-40a4-94dc-6f80934e0edf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zaleplon
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA090374
- Marketing category
- ANDA
- Marketing start
- 2024-02-17
- Substance
- ZALEPLON
- Active strength
- 5 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 | 5 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 |
|---|
| 69452-364-20 | Zaleplon | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-364 | ZALEPLON CAPSULE [BIONPHARMA INC.] | 1 | Current NDC, 1 package rows | 20240217_53103d2f-4453-49a8-9e36-888d919879f6.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 |
|---|
| 69452-364-20 | 69452036420 | 100 CAPSULE in 1 BOTTLE (69452-364-20) | 100 capsule | 2024-02-17 | No | No | Current |