Zaleplon
- Product NDC
- 0054-0084
- 11-digit product format
- 000540084
- Labeler code
- 0054
- Product ID
- 0054-0084_d97e7e61-defc-47f5-aeca-11cecae47e79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zaleplon
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA077237
- Marketing category
- ANDA
- Marketing start
- 2008-06-06
- 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 |
|---|
| 0054-0084-25 | Zaleplon | 100 in 1 BOTTLE | CAPSULE | 100 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ZALEPLON | ACTIVE INGREDIENT | S62U433RMH | ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] | 5 | |
| ZALEPLON | ACTIVE MOIETY | S62U433RMH | ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] | 5 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] | 5 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0084 | ZALEPLON CAPSULE [HIKMA PHARMACEUTICALS USA INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20250330_cadd9d75-2139-4fab-94ce-2992e6a55780.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 |
|---|
| 0054-0084-25 | 00054008425 | 100 CAPSULE in 1 BOTTLE (0054-0084-25) | 100 capsule | 2008-06-06 | 0000-00-00 | No | No | Current |