Modafinil
- Product NDC
- 0378-5575
- 11-digit product format
- 003785575
- Labeler code
- 0378
- Product ID
- 0378-5575_f6947bbc-082d-48f6-ab5e-06610359865d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076594
- Marketing category
- ANDA
- Marketing start
- 2012-08-10
- Marketing end
- 0000-00-00
- Substance
- MODAFINIL
- Active strength
- 200 mg/1
- Pharmacologic classes
- Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MODAFINIL | ACTIVE INGREDIENT | R3UK8X3U3D | MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MODAFINIL | ACTIVE MOIETY | R3UK8X3U3D | MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-5575-05 | 00378557505 | 500 TABLET in 1 BOTTLE, PLASTIC (0378-5575-05) | 500 tablet | 2012-08-10 | 0000-00-00 | No | No | Current |
| 0378-5575-93 | 00378557593 | 30 TABLET in 1 BOTTLE, PLASTIC (0378-5575-93) | 30 tablet | 2012-08-10 | 0000-00-00 | No | No | Current |