Extended Phenytoin Sodium
- Product NDC
- 10135-603
- 11-digit product format
- 101350603
- Labeler code
- 10135
- Product ID
- 10135-603_13643d1e-4b4d-4e27-9726-59cf52269778
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA040765
- Marketing category
- ANDA
- Marketing start
- 2015-08-01
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-603-01 | Extended Phenytoin Sodium | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 1 |
| 10135-603-10 | Extended Phenytoin Sodium | 1000 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1000 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PHENYTOIN SODIUM | ACTIVE INGREDIENT | 4182431BJH | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 1 | |
| PHENYTOIN | ACTIVE MOIETY | 6158TKW0C5 | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 1 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-603 | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 1 | Legacy NDC, 2 package rows | 20150910_f46729db-f841-4bfc-8a29-7a09a48fc9d6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10135-603-01 | 10135060301 | 100 in 1 BOTTLE | Historical |
| 10135-603-10 | 10135060310 | 1000 in 1 BOTTLE | Historical |