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NDC 69452-0347-20 ESZOPICLONE 1 mg/1 Details
ESZOPICLONE 1 mg/1
ESZOPICLONE is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bionpharma 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: 69452-0347-20Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Eszopiclone
Product Information
| NDC | 69452-0347 |
|---|---|
| Product ID | 69452-347_903d952f-704a-4227-a829-5bddbd5793cb |
| Associated GPIs | |
| GCN Sequence Number | 058484 |
| GCN Sequence Number Description | eszopiclone TABLET 1 MG ORAL |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 23927 |
| 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 | 1 |
| Active Ingredient Units | mg/1 |
| Substance Name | ESZOPICLONE |
| Labeler Name | Bionpharma Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA091113 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69452-0347-20 (69452034720)
| NDC Package Code | 69452-347-20 |
|---|---|
| Billing NDC | 69452034720 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-347-20) |
| Marketing Start Date | 2022-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |