modafinil
- Product NDC
- 68258-7981
- 11-digit product format
- 682587981
- Labeler code
- 68258
- Product ID
- 68258-7981_d0d3dac4-a8c8-4c05-abfa-aad2ee2f41f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- NDA020717
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-03-29
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 68258-7981-3 | modafinil | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| modafinil | ACTIVE INGREDIENT | R3UK8X3U3D | MODAFINIL TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| modafinil | ACTIVE MOIETY | R3UK8X3U3D | MODAFINIL TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MODAFINIL TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MODAFINIL TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| lactose | INACTIVE INGREDIENT | J2B2A4N98G | MODAFINIL TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | MODAFINIL TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | MODAFINIL TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MODAFINIL TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68258-7981 | MODAFINIL TABLET [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 1 package rows | 20131030_ca740635-df30-46af-9202-55af9204f381.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68258-7981-3 | 68258798103 | 30 in 1 BOTTLE | Historical |