Modafinil
- Product NDC
- 71335-1096
- 11-digit product format
- 713351096
- Labeler code
- 71335
- Product ID
- 71335-1096_3ead2d94-99ce-4f14-a9df-876eaa8d8882
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202700
- Marketing category
- ANDA
- Marketing start
- 2017-06-30
- 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
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71335-1096-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1638-111a-e063-dadaa90a10e2 | 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, for oral use, C-IV Initial U.S. Approval: 1998 |
| 71335-1096-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1638-111a-e063-dadaa90a10e2 | 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, for oral use, C-IV Initial U.S. Approval: 1998 |
| 71335-1096-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1638-111a-e063-dadaa90a10e2 | 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, for oral use, C-IV Initial U.S. Approval: 1998 |
| 71335-1096-4 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1638-111a-e063-dadaa90a10e2 | 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, for oral use, C-IV Initial U.S. Approval: 1998 |
| 71335-1096-5 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1638-111a-e063-dadaa90a10e2 | 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, for oral use, C-IV Initial U.S. Approval: 1998 |
| 71335-1096-6 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1638-111a-e063-dadaa90a10e2 | 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, for oral use, C-IV Initial U.S. Approval: 1998 |
| 71335-1096-7 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1638-111a-e063-dadaa90a10e2 | 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, for oral use, C-IV Initial U.S. Approval: 1998 |
| 71335-1096-8 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1638-111a-e063-dadaa90a10e2 | 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, for oral use, C-IV Initial U.S. Approval: 1998 |
| 71335-1096-9 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1638-111a-e063-dadaa90a10e2 | 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, for oral use, C-IV Initial U.S. Approval: 1998 |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1096 | MODAFINIL TABLET [BRYANT RANCH PREPACK] | 4 | Legacy NDC, 9 package rows | 20220203_3ead2d94-99ce-4f14-a9df-876eaa8d8882.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 |
|---|
| 71335-1096-1 | 71335109601 | 30 TABLET in 1 BOTTLE (71335-1096-1) | 30 tablet | 2019-02-13 | 0000-00-00 | No | No | Current |
| 71335-1096-2 | 71335109602 | 18 TABLET in 1 BOTTLE (71335-1096-2) | 18 tablet | 2019-02-13 | 0000-00-00 | No | No | Current |
| 71335-1096-3 | 71335109603 | 16 TABLET in 1 BOTTLE (71335-1096-3) | 16 tablet | 2019-02-13 | 0000-00-00 | No | No | Current |
| 71335-1096-4 | 71335109604 | 8 TABLET in 1 BOTTLE (71335-1096-4) | 8 tablet | 2019-02-13 | 0000-00-00 | No | No | Current |
| 71335-1096-5 | 71335109605 | 10 TABLET in 1 BOTTLE (71335-1096-5) | 10 tablet | 2019-02-13 | 0000-00-00 | No | No | Current |
| 71335-1096-6 | 71335109606 | 60 TABLET in 1 BOTTLE (71335-1096-6) | 60 tablet | 2019-02-13 | 0000-00-00 | No | No | Current |
| 71335-1096-7 | 71335109607 | 90 TABLET in 1 BOTTLE (71335-1096-7) | 90 tablet | 2019-02-13 | 0000-00-00 | No | No | Current |
| 71335-1096-8 | 71335109608 | 45 TABLET in 1 BOTTLE (71335-1096-8) | 45 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-1096-9 | 71335109609 | 180 TABLET in 1 BOTTLE (71335-1096-9) | 180 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |