Modafinil
- Product NDC
- 68071-5121
- 11-digit product format
- 680715121
- Labeler code
- 68071
- Product ID
- 68071-5121_1b547633-2137-67d7-e063-6294a90a1b5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA202566
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- Substance
- MODAFINIL
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R3UK8X3U3D |
| Rxcui | 260218 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-5121-3 | 2024-06-20 | C162847 | 48780-1 | ba0f9c33-4914-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use modafinil tablets safely and effectively. See full prescribing information for modafinil tablets. MODAFINIL tablets USP, for oral use, CIV Initial U.S. Approval: 1998 |
| 68071-5121-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4914-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use modafinil tablets safely and effectively. See full prescribing information for modafinil tablets. MODAFINIL tablets USP, for oral use, CIV Initial U.S. Approval: 1998 |
| 68071-5121-3 | 2021-02-22 | C162847 | 48780-1 | ba0f9c33-4914-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use modafinil tablets safely and effectively. See full prescribing information for modafinil tablets. MODAFINIL tablets USP, for oral use, CIV Initial U.S. Approval: 1998 |
| 68071-5121-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4914-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use modafinil tablets safely and effectively. See full prescribing information for modafinil tablets. MODAFINIL tablets USP, for oral use, CIV Initial U.S. Approval: 1998 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-5121-3 | Modafinil | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-5121 | MODAFINIL TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240621_98e54b10-8ae0-7c43-e053-2a95a90ae8bb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-5121-3 | 68071512103 | 30 TABLET in 1 BOTTLE (68071-5121-3) | 30 tablet | 2019-12-04 | 0000-00-00 | No | No | Current |