Modafinil
- Product NDC
- 71610-989
- 11-digit product format
- 716100989
- Labeler code
- 71610
- Product ID
- 71610-989_4aa301e3-c34b-232a-e063-6394a90a86d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078963
- Marketing category
- ANDA
- Marketing start
- 2022-02-28
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Modafinil
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MODAFINIL | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R3UK8X3U3D |
| Rxcui | 205324 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-989-30 | Modafinil | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 71610-989-53 | Modafinil | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 71610-989-60 | Modafinil | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-989-30 | 71610098930 | 30 TABLET in 1 BOTTLE (71610-989-30) | 30 tablet | 2026-02-10 | No | No | Historical |
| 71610-989-53 | 71610098953 | 60 TABLET in 1 BOTTLE (71610-989-53) | 60 tablet | 2026-02-10 | No | No | Historical |
| 71610-989-60 | 71610098960 | 90 TABLET in 1 BOTTLE (71610-989-60) | 90 tablet | 2026-02-10 | No | No | Historical |