Modafinil
- Product NDC
- 43353-831
- 11-digit product format
- 433530831
- Labeler code
- 43353
- Product ID
- 43353-831_adec9b98-1867-41a0-9288-3185c095a6fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-831-30 | Modafinil | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 1 |
| 43353-831-53 | Modafinil | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 1 |
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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-831 | MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC, 2 package rows | 20140415_514d242d-48c9-4162-a85a-a433b41107ac.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-831-30 | 43353083130 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 43353-831-53 | 43353083153 | 60 in 1 BOTTLE, PLASTIC | Historical |