EXTENDED PHENYTOIN SODIUM
- Product NDC
- 64679-720
- 11-digit product format
- 646790720
- Labeler code
- 64679
- Product ID
- 64679-720_d2c223ad-1f57-4111-acae-bee711f4c8cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EXTENDED PHENYTOIN SODIUM
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Wockhardt USA LLC.
- Application
- ANDA040732
- Marketing category
- ANDA
- Marketing start
- 2008-01-30
- Marketing end
- 0000-00-00
- Substance
- PHENYTOIN SODIUM
- Active strength
- 100 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| be8c0c29-be12-4cae-8e3b-1c71ed6b952c | Product name | 2 | 20250626 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| e3d31abf-5149-4e77-89a8-0dc73ec106f9 | Product name | 1 | 20210525 |
| b251e19b-cfda-4a5c-8c9c-f4dad5d55ecb | Product name | 2 | 20200303 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 031bbc61-0564-1f35-2716-aa5c1d139248 | Product name | 2 | 20141218 |
| cc830ceb-037c-a5c3-ee14-3d82c0e89e70 | Product name | 1 | 20140508 |
| eafc3fd3-6834-3129-5bbb-8a9a495691ab | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64679-720-01 | 2024-10-29 | C162847 | 48780-1 | 0191ceaa-62f5-198a-e063-dbdaa90aec3e | 81661cf9-430b-4f66-88fd-2cbd5b114e3b |
| 64679-720-02 | 2024-10-29 | C162847 | 48780-1 | 0191ceaa-62f5-198a-e063-dbdaa90aec3e | 81661cf9-430b-4f66-88fd-2cbd5b114e3b |
| 64679-720-01 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-62f5-198a-e063-dbdaa90aec3e | 81661cf9-430b-4f66-88fd-2cbd5b114e3b |
| 64679-720-02 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-62f5-198a-e063-dbdaa90aec3e | 81661cf9-430b-4f66-88fd-2cbd5b114e3b |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64679-720-01 | EA - Each | 64679-720 | af548daa-6696-49b3-b7b3-b315ae5846cd | 1 | 2012-07-24 |
| 64679-720-02 | EA - Each | 64679-720 | cde86135-6947-4f91-ba1a-c180b177aea5 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | 73273069-249a-423e-b634-a73af6632ba3 | 2 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | 73273069-249a-423e-b634-a73af6632ba3 | 2 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | 73273069-249a-423e-b634-a73af6632ba3 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64679-720-01 | 64679072001 | 100 CAPSULE in 1 BOTTLE (64679-720-01) | 100 capsule | 2008-01-30 | 0000-00-00 | No | No | Current |
| 64679-720-02 | 64679072002 | 1000 CAPSULE in 1 BOTTLE (64679-720-02) | 1000 capsule | 2008-01-30 | 0000-00-00 | No | No | Current |