Modafinil
- Product NDC
- 49884-535
- 11-digit product format
- 498840535
- Labeler code
- 49884
- Product ID
- 49884-535_2a0cf156-42e6-4829-8f2c-5fe0fcd3858a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Par Pharmaceutical Inc.
- Application
- NDA020717
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-04-06
- Marketing end
- 2020-08-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 91b7dea8-da1b-abb1-9750-2e680cd894b6 | Product name | 2 | 20171005 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49884-535-09 | EA - Each | 49884-535 | bc3e6e94-3d56-4c88-9e40-a0c300b149ed | 1 | 2014-01-04 |
| 49884-535-11 | EA - Each | 49884-535 | 9c677fe7-019d-4a06-b70a-254cab7c2609 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MODAFINIL | ACTIVE INGREDIENT | R3UK8X3U3D | MODAFINIL TABLET [STAT RX USA LLC] | 1 | |
| MODAFINIL | ACTIVE MOIETY | R3UK8X3U3D | MODAFINIL TABLET [STAT RX USA LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MODAFINIL TABLET [STAT RX USA LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MODAFINIL TABLET [STAT RX USA LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MODAFINIL TABLET [STAT RX USA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MODAFINIL TABLET [STAT RX USA LLC] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | MODAFINIL TABLET [STAT RX USA LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MODAFINIL TABLET [STAT RX USA LLC] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 205324 | modafinil 200 MG Oral Tablet | PSN | 6a8a2185-52f9-4952-a361-514e44b1cd44 | 1 |
| 205324 | modafinil 200 MG Oral Tablet | PSN | eba3a655-074b-46b3-88cf-3e6b2c0c8b15 | 1 |
| 205324 | modafinil 200 MG Oral Tablet | SCD | 6a8a2185-52f9-4952-a361-514e44b1cd44 | 1 |
| 205324 | modafinil 200 MG Oral Tablet | SCD | eba3a655-074b-46b3-88cf-3e6b2c0c8b15 | 1 |