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NDC 69452-0343-13 Modafinil 200 mg/1 Details
Modafinil 200 mg/1
Modafinil is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bionpharma Inc.. The primary component is MODAFINIL.
MedlinePlus Drug Summary
Modafinil 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). Modafinil 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 doesn't get enough restful sleep). Modafinil 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: 69452-0343-13Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Modafinil
Product Information
| NDC | 69452-0343 |
|---|---|
| Product ID | 69452-343_45322b3a-fdbe-466f-a2d3-b64e12b36efe |
| Associated GPIs | 61400024000320 |
| GCN Sequence Number | 041478 |
| GCN Sequence Number Description | modafinil TABLET 200 MG ORAL |
| HIC3 | H8Q |
| HIC3 Description | NARCOLEPSY AND SLEEP DISORDER THERAPY AGENTS |
| GCN | 26102 |
| HICL Sequence Number | 010865 |
| HICL Sequence Number Description | MODAFINIL |
| Brand/Generic | Generic |
| Proprietary Name | Modafinil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Modafinil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | MODAFINIL |
| Labeler Name | Bionpharma Inc. |
| Pharmaceutical Class | Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA078963 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69452-0343-13 (69452034313)
| NDC Package Code | 69452-343-13 |
|---|---|
| Billing NDC | 69452034313 |
| Package | 30 TABLET in 1 BOTTLE, PLASTIC (69452-343-13) |
| Marketing Start Date | 2022-02-28 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.41955 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | MODAFINIL 200 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |