Extended Phenytoin Sodium
- Product NDC
- 65862-692
- 11-digit product format
- 658620692
- Labeler code
- 65862
- Product ID
- 65862-692_8b54186e-7485-40f0-8fe0-58b417dfcb7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA204309
- Marketing category
- ANDA
- Marketing start
- 2015-06-10
- Substance
- PHENYTOIN SODIUM
- Active strength
- 100 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Extended Phenytoin Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYTOIN SODIUM | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4182431BJH |
| Rxcui | 855671 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-692-01 | Extended Phenytoin Sodium | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 65862-692-10 | Extended Phenytoin Sodium | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 10 |
| 65862-692-78 | Extended Phenytoin Sodium | 10 in 1 CARTON | CAPSULE | 10 | | 10 |
| 65862-692-99 | Extended Phenytoin Sodium | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-692 | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED] | 10 | Current NDC, Legacy NDC, 4 package rows | 20231006_5362ea50-38a4-48b4-a85b-d634c3d8b91a.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 |
|---|
| 65862-692-01 | 65862069201 | 100 CAPSULE in 1 BOTTLE (65862-692-01) | 100 capsule | 2015-06-10 | 0000-00-00 | No | No | Current |
| 65862-692-10 | 65862069210 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 65862-692-26 | 65862069226 | 2500 CAPSULE in 1 BAG (65862-692-26) | 2500 capsule | 10-JUN-15 | | | | Current |
| 65862-692-78 | 65862069278 | 10 BLISTER PACK in 1 CARTON (65862-692-78) / 10 CAPSULE in 1 BLISTER PACK (65862-692-10) | 10 blister pack | 2015-06-10 | 0000-00-00 | No | No | Current |
| 65862-692-99 | 65862069299 | 1000 CAPSULE in 1 BOTTLE (65862-692-99) | 1000 capsule | 2015-06-10 | 0000-00-00 | No | No | Current |