Dilantin
- Product NDC
- 70518-0980
- 11-digit product format
- 705180980
- Labeler code
- 70518
- Product ID
- 70518-0980_dfc204b4-0649-d3ca-e053-2995a90ad220
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA084349
- Marketing category
- ANDA
- Marketing start
- 2018-01-22
- Marketing end
- 0000-00-00
- Substance
- PHENYTOIN SODIUM
- Active strength
- 30 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- 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 |
|---|
| 70518-0980-0 | 2025-11-13 | C162847 | 48780-1 | d6a99b39-d430-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953 |
| 70518-0980-1 | 2025-11-13 | C162847 | 48780-1 | d6a99b39-d430-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953 |
| 70518-0980-0 | 2024-01-30 | C162847 | 48780-1 | d6a99b39-d430-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953 |
| 70518-0980-1 | 2024-01-30 | C162847 | 48780-1 | d6a99b39-d430-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953 |
| 70518-0980-0 | 2022-06-04 | C162847 | 48780-1 | d6a99b39-d430-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953 |
| 70518-0980-1 | 2022-06-04 | C162847 | 48780-1 | d6a99b39-d430-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953 |
| 70518-0980-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d430-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953 |
| 70518-0980-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d430-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-0980 | DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] | 5 | Legacy NDC | 20220604_f1d41925-3be0-42a8-86f8-181569399c5b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-0980-0 | 70518098000 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-0980-0) | | 2018-01-22 | 0000-00-00 | No | No | Current |
| 70518-0980-1 | 70518098001 | 100 POUCH in 1 BOX (70518-0980-1) > 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-0980-2) | 100 pouch | 2020-01-06 | 0000-00-00 | No | No | Current |