zaleplon
- Product NDC
- 29300-131
- 11-digit product format
- 293000131
- Labeler code
- 29300
- Product ID
- 29300-131_24b4fbb6-3d16-48f7-864c-71e85813a9a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zaleplon
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA078989
- Marketing category
- ANDA
- Marketing start
- 2009-05-05
- 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 |
|---|
| 29300-131-01 | zaleplon | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 10 |
| 29300-131-05 | zaleplon | 500 in 1 BOTTLE, PLASTIC | CAPSULE | 500 | | 10 |
| 29300-131-13 | zaleplon | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ZALEPLON | ACTIVE INGREDIENT | S62U433RMH | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| ZALEPLON | ACTIVE MOIETY | S62U433RMH | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| ZALEPLON | ACTIVE INGREDIENT | S62U433RMH | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ZALEPLON | ACTIVE INGREDIENT | S62U433RMH | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| ZALEPLON | ACTIVE MOIETY | S62U433RMH | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ZALEPLON | ACTIVE MOIETY | S62U433RMH | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-131 | ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20210626_57a1a11d-7767-4caf-b98a-75d7561d9165.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 |
|---|
| 29300-131-01 | 29300013101 | 100 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-01) | 100 capsule | 2009-05-05 | 0000-00-00 | No | No | Current |
| 29300-131-05 | 29300013105 | 500 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-05) | 500 capsule | 2009-05-05 | 0000-00-00 | No | No | Current |
| 29300-131-13 | 29300013113 | 30 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-13) | 30 capsule | 2009-05-05 | 0000-00-00 | No | No | Current |