PHENYTOIN SODIUM
- Product NDC
- 39822-4050
- 11-digit product format
- 398224050
- Labeler code
- 39822
- Product ID
- 39822-4050_492a8728-d60f-41ea-bedd-ead7375f3ad5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PHENYTOIN SODIUM
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- X-GEN Pharmaceuticals, Inc.
- Application
- ANDA040573
- Marketing category
- ANDA
- Marketing start
- 2011-05-02
- Marketing end
- 0000-00-00
- Substance
- PHENYTOIN SODIUM
- Active strength
- 50 mg/mL
- 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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 39822-4050-3 | 2020-02-03 | C162847 | 48780-1 | 9d75b9d0-3937-f424-e053-dadaa90a57ce | ab923d09-747d-4527-9bdf-2c807a5775d2 |
| 39822-4050-6 | 2020-02-03 | C162847 | 48780-1 | 9d75b9d0-3937-f424-e053-dadaa90a57ce | ab923d09-747d-4527-9bdf-2c807a5775d2 |
| 39822-4050-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3937-f424-e053-dadaa90a57ce | ab923d09-747d-4527-9bdf-2c807a5775d2 |
| 39822-4050-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3937-f424-e053-dadaa90a57ce | ab923d09-747d-4527-9bdf-2c807a5775d2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 39822-4050-2 | ML - Milliliter | 39822-4050 | 13858b9d-e930-4f93-bb30-be12b6fa6b67 | 1 | 2012-07-24 |
| 39822-4050-3 | ML - Milliliter | 39822-4050 | 9e5014b4-e463-4a60-b539-be6e1756ece7 | 1 | 2012-07-24 |
| 39822-4050-5 | ML - Milliliter | 39822-4050 | d46ca250-4a5f-41c3-99a6-232436b123bf | 1 | 2012-07-24 |
| 39822-4050-6 | ML - Milliliter | 39822-4050 | ea675d7a-05c5-48af-84a6-d37849457e76 | 1 | 2012-07-24 |