Modafinil
- Product NDC
- 23155-862
- 11-digit product format
- 231550862
- Labeler code
- 23155
- Product ID
- 23155-862_d8fc4961-6cbc-44fc-be5f-63127fff98f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA207196
- Marketing category
- ANDA
- Marketing start
- 2024-02-21
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Modafinil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MODAFINIL | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R3UK8X3U3D |
| Rxcui | 205324, 260218 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 23155-862-01 | Modafinil | 100 in 1 BOTTLE | TABLET | 100 | | 13 |
| 23155-862-03 | Modafinil | 30 in 1 BOTTLE | TABLET | 30 | | 13 |
| 23155-862-05 | Modafinil | 500 in 1 BOTTLE | TABLET | 500 | | 13 |
| 23155-862-09 | Modafinil | 90 in 1 BOTTLE | TABLET | 90 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-862 | MODAFINIL TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 13 | Current NDC, 4 package rows | 20240223_1a309416-bd6a-45b1-982f-b689b097453d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 23155-862-01 | 23155086201 | 100 TABLET in 1 BOTTLE (23155-862-01) | 100 tablet | 2024-02-21 | No | No | Current |
| 23155-862-03 | 23155086203 | 30 TABLET in 1 BOTTLE (23155-862-03) | 30 tablet | 2024-02-21 | No | No | Current |
| 23155-862-05 | 23155086205 | 500 TABLET in 1 BOTTLE (23155-862-05) | 500 tablet | 2024-02-21 | No | No | Current |
| 23155-862-09 | 23155086209 | 90 TABLET in 1 BOTTLE (23155-862-09) | 90 tablet | 2024-02-21 | No | No | Current |