Modafinil
- Product NDC
- 46708-386
- 11-digit product format
- 467080386
- Labeler code
- 46708
- Product ID
- 46708-386_975cac47-5a4b-4a5d-a8c5-2aea808f30ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Modafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA202700
- Marketing category
- ANDA
- Marketing start
- 2017-06-30
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 46708-386-10 | 2023-02-01 | C162847 | 48780-1 | f386c64a-3c7d-0266-e053-dadaa90a7c1a | 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 |
| 46708-386-30 | 2023-02-01 | C162847 | 48780-1 | f386c64a-3c7d-0266-e053-dadaa90a7c1a | 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 |
| 46708-386-60 | 2023-02-01 | C162847 | 48780-1 | f386c64a-3c7d-0266-e053-dadaa90a7c1a | 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 |
| 46708-386-90 | 2023-02-01 | C162847 | 48780-1 | f386c64a-3c7d-0266-e053-dadaa90a7c1a | 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 |
| 46708-386-91 | 2023-02-01 | C162847 | 48780-1 | f386c64a-3c7d-0266-e053-dadaa90a7c1a | 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 |
| 46708-386-10 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3c7d-0266-e053-dadaa90a7c1a | 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 |
| 46708-386-30 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3c7d-0266-e053-dadaa90a7c1a | 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 |
| 46708-386-60 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3c7d-0266-e053-dadaa90a7c1a | 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 |
| 46708-386-90 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3c7d-0266-e053-dadaa90a7c1a | 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 |
| 46708-386-91 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3c7d-0266-e053-dadaa90a7c1a | 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-386-10 | Modafinil | 100 in 1 CARTON | TABLET | 100 | | 3 |
| 46708-386-30 | Modafinil | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 46708-386-60 | Modafinil | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 46708-386-90 | Modafinil | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
| 46708-386-91 | Modafinil | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-386 | MODAFINIL TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 5 package rows | 20230202_5b8496fe-b647-4ce6-aeef-71245712e46f.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 |
|---|
| 46708-386-10 | 46708038610 | 100 TABLET in 1 CARTON (46708-386-10) | 100 tablet | 2017-06-30 | 0000-00-00 | No | No | Current |
| 46708-386-30 | 46708038630 | 30 TABLET in 1 BOTTLE (46708-386-30) | 30 tablet | 2017-06-30 | 0000-00-00 | No | No | Current |
| 46708-386-60 | 46708038660 | 60 TABLET in 1 BOTTLE (46708-386-60) | 60 tablet | 2017-06-30 | 0000-00-00 | No | No | Current |
| 46708-386-90 | 46708038690 | 90 TABLET in 1 BOTTLE (46708-386-90) | 90 tablet | 2017-06-30 | 0000-00-00 | No | No | Current |
| 46708-386-91 | 46708038691 | 1000 TABLET in 1 BOTTLE (46708-386-91) | 1000 tablet | 2017-06-30 | 0000-00-00 | No | No | Current |