ZALEPLON
- Product NDC
- 71335-1054
- 11-digit product format
- 713351054
- Labeler code
- 71335
- Product ID
- 71335-1054_d6c60218-c971-45ca-9845-b0123001f37b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ZALEPLON
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
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 |
|---|
| 71335-1054-1 | ZALEPLON | 15 in 1 BOTTLE | CAPSULE | 15 | | 3 |
| 71335-1054-2 | ZALEPLON | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
| 71335-1054-3 | ZALEPLON | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
| 71335-1054-4 | ZALEPLON | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1054 | ZALEPLON CAPSULE [BRYANT RANCH PREPACK] | 3 | Current NDC, Legacy NDC, 4 package rows | 20240602_bec67c5d-9f8f-4490-a0b4-9b7905b565f1.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 |
|---|
| 71335-1054-1 | 71335105401 | 15 CAPSULE in 1 BOTTLE (71335-1054-1) | 15 capsule | 2024-05-30 | 0000-00-00 | No | No | Current |
| 71335-1054-2 | 71335105402 | 30 CAPSULE in 1 BOTTLE (71335-1054-2) | 30 capsule | 2019-01-10 | 0000-00-00 | No | No | Current |
| 71335-1054-3 | 71335105403 | 60 CAPSULE in 1 BOTTLE (71335-1054-3) | 60 capsule | 2024-05-30 | 0000-00-00 | No | No | Current |
| 71335-1054-4 | 71335105404 | 90 CAPSULE in 1 BOTTLE (71335-1054-4) | 90 capsule | 2024-05-30 | 0000-00-00 | No | No | Current |