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NDC 43063-0795-30 Eszopiclone 3 mg/1 Details
Eszopiclone 3 mg/1
Eszopiclone is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is ESZOPICLONE.
MedlinePlus Drug Summary
Eszopiclone is used to treat insomnia (difficulty falling asleep or staying asleep). Eszopiclone is in a class of medications called hypnotics. It works by slowing activity in the brain to allow sleep.
Related Packages: 43063-0795-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Eszopiclone
Product Information
| NDC | 43063-0795 |
|---|---|
| Product ID | 43063-795_05ba12a9-806f-9532-e063-6294a90a0831 |
| Associated GPIs | 60204035000340 |
| GCN Sequence Number | 058482 |
| GCN Sequence Number Description | eszopiclone TABLET 3 MG ORAL |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 23925 |
| HICL Sequence Number | 026791 |
| HICL Sequence Number Description | ESZOPICLONE |
| Brand/Generic | Generic |
| Proprietary Name | Eszopiclone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Eszopiclone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 3 |
| Active Ingredient Units | mg/1 |
| Substance Name | ESZOPICLONE |
| Labeler Name | PD-Rx Pharmaceuticals, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA091124 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43063-0795-30 (43063079530)
| NDC Package Code | 43063-795-30 |
|---|---|
| Billing NDC | 43063079530 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-795-30) |
| Marketing Start Date | 2017-10-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |