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NDC 43063-0783-10 zaleplon 10 mg/1 Details
zaleplon 10 mg/1
zaleplon is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is ZALEPLON.
MedlinePlus Drug Summary
Zaleplon is used on a short-term basis to treat insomnia (difficulty falling asleep). Zaleplon does not help you to stay asleep longer or decrease the number of times that you awaken during the night. Zaleplon is in a class of medications called hypnotics. It works by slowing activity in the brain to allow sleep.
Related Packages: 43063-0783-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Zaleplon
Product Information
| NDC | 43063-0783 |
|---|---|
| Product ID | 43063-783_065b01ed-7a80-4168-e063-6394a90a3b5e |
| Associated GPIs | 60204070000130 |
| GCN Sequence Number | 042994 |
| GCN Sequence Number Description | zaleplon CAPSULE 10 MG ORAL |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 92723 |
| HICL Sequence Number | 020347 |
| HICL Sequence Number Description | ZALEPLON |
| Brand/Generic | Generic |
| Proprietary Name | zaleplon |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | zaleplon |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | ZALEPLON |
| Labeler Name | PD-Rx Pharmaceuticals, Inc. |
| Pharmaceutical Class | Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA078989 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43063-0783-10 (43063078310)
| NDC Package Code | 43063-783-10 |
|---|---|
| Billing NDC | 43063078310 |
| Package | 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-783-10) |
| Marketing Start Date | 2017-08-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |