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NDC 65862-0807-05 Armodafinil 250 mg/1 Details
Armodafinil 250 mg/1
Armodafinil is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is ARMODAFINIL.
MedlinePlus Drug Summary
Armodafinil is used to treat excessive sleepiness caused by narcolepsy (a condition that causes excessive daytime sleepiness) or shift work sleep disorder (sleepiness during scheduled waking hours and difficulty falling asleep or staying asleep during scheduled sleeping hours in people who work at night or on rotating shifts). Armodafinil is also used along with breathing devices or other treatments to prevent excessive sleepiness caused by obstructive sleep apnea/hypopnea syndrome (OSAHS; a sleep disorder in which the patient briefly stops breathing or breathes shallowly many times during sleep and therefore does not get enough restful sleep). Armodafinil is in a class of medications called wakefulness-promoting agents. It works by changing the amounts of certain natural substances in the area of the brain that controls sleep and wakefulness.
Related Packages: 65862-0807-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Armodafinil
Product Information
| NDC | 65862-0807 |
|---|---|
| Product ID | 65862-807_e05b6e91-7f79-41ee-ada6-cc52a92f9dac |
| Associated GPIs | 61400010000340 |
| GCN Sequence Number | 062821 |
| GCN Sequence Number Description | armodafinil TABLET 250 MG ORAL |
| HIC3 | H8Q |
| HIC3 Description | NARCOLEPSY AND SLEEP DISORDER THERAPY AGENTS |
| GCN | 98592 |
| HICL Sequence Number | 034868 |
| HICL Sequence Number Description | ARMODAFINIL |
| Brand/Generic | Generic |
| Proprietary Name | Armodafinil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Armodafinil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 250 |
| Active Ingredient Units | mg/1 |
| Substance Name | ARMODAFINIL |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | n/a |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA206069 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0807-05 (65862080705)
| NDC Package Code | 65862-807-05 |
|---|---|
| Billing NDC | 65862080705 |
| Package | 500 TABLET in 1 BOTTLE (65862-807-05) |
| Marketing Start Date | 2018-03-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |