Phenytoin Sodium
- Product NDC
- 21695-167
- 11-digit product format
- 216950167
- Labeler code
- 21695
- Product ID
- 21695-167_b7758662-dcd2-4a02-933f-8a3de70cf551
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA040684
- Marketing category
- ANDA
- Marketing start
- 2006-09-05
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 21695-167-30 | Phenytoin Sodium | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 1 |
| 21695-167-72 | Phenytoin Sodium | 120 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 120 | | 1 |
| 21695-167-90 | Phenytoin Sodium | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Phenytoin Sodium | ACTIVE INGREDIENT | 4182431BJH | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| Phenytoin | ACTIVE MOIETY | 6158TKW0C5 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| butylparaben | INACTIVE INGREDIENT | 3QPI1U3FV8 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| edetate calcium disodium | INACTIVE INGREDIENT | 25IH6R4SGF | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| sodium propionate | INACTIVE INGREDIENT | DK6Y9P42IN | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-167 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 3 package rows | 20110113_b7758662-dcd2-4a02-933f-8a3de70cf551.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-167-30 | 21695016730 | 30 in 1 BOTTLE | Historical |
| 21695-167-72 | 21695016772 | 120 in 1 BOTTLE | Historical |
| 21695-167-90 | 21695016790 | 90 in 1 BOTTLE | Historical |