ZALEPLON
- Product NDC
- 52959-957
- 11-digit product format
- 529590957
- Labeler code
- 52959
- Product ID
- 52959-957_f99f26bc-5e6c-4b5a-9657-6bc3861fa5e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ZALEPLON
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA078989
- Marketing category
- ANDA
- Marketing start
- 2010-12-15
- Marketing end
- 0000-00-00
- Substance
- ZALEPLON
- Active strength
- 10 mg/1
- Pharmacologic classes
- gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 52959-957-30 | ZALEPLON | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 52959-957-60 | ZALEPLON | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ZALEPLON | ACTIVE INGREDIENT | S62U433RMH | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| ZALEPLON | ACTIVE MOIETY | S62U433RMH | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| FERRIC OXIDE BLACK | INACTIVE INGREDIENT | XM0M87F357 | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| SILICON DIOXIDE, COLLOIDAL | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-957 | ZALEPLON (ZALEPLON) CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 2 package rows | 20110901_4ccb8d3d-31ef-49ff-8567-c620b9d74f8c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-957-30 | 52959095730 | 30 in 1 BOTTLE | Historical |
| 52959-957-60 | 52959095760 | 60 in 1 BOTTLE | Historical |