Phenytoin Sodium
- Product NDC
- 51672-4111
- 11-digit product format
- 516724111
- Labeler code
- 51672
- Product ID
- 51672-4111_4d4421be-75f8-2639-e063-6294a90accd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA040684
- Marketing category
- ANDA
- Marketing start
- 2006-09-05
- 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
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 51672-4111 | 51672-4111-0 | D | Discontinued by firm | 2026-08-11 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040684-001 | EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040684-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040684-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | AB | 2006-09-05 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040684-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040684-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040684-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040684-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040684-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040684-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040684-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040684-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040684-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040684-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040684-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040684-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040684-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040684-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040684-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040684-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040684-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040684-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040684-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040684-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040684-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040684-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040684-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040684-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040684-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040684-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040684-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040684-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040684-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040684-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040684-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040684-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040684-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040684-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040684-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040684-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040684-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040684-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040684-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040684-001 | AB | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phenytoin Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYTOIN SODIUM | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4182431BJH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 855671 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 601f7353-225d-4a5d-9810-3869c2c21874 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| be8c0c29-be12-4cae-8e3b-1c71ed6b952c | Product name | 2 | 20250626 |
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| e3d31abf-5149-4e77-89a8-0dc73ec106f9 | Product name | 1 | 20210525 |
| b251e19b-cfda-4a5c-8c9c-f4dad5d55ecb | Product name | 2 | 20200303 |
| 031bbc61-0564-1f35-2716-aa5c1d139248 | Product name | 2 | 20141218 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| cc830ceb-037c-a5c3-ee14-3d82c0e89e70 | Product name | 1 | 20140508 |
| eafc3fd3-6834-3129-5bbb-8a9a495691ab | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51672-4111-0 | Phenytoin Sodium | 10 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 10 | 16 | |
| 51672-4111-0 | Phenytoin Sodium | 10 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 10 | 16 | |
| 51672-4111-1 | Phenytoin Sodium | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 16 | |
| 51672-4111-3 | Phenytoin Sodium | 1000 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1000 | 16 | |
| 51672-4111-6 | Phenytoin Sodium | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-4111-1 | EA - Each | 51672-4111 | 0f23fecb-57c3-4685-be86-4d4a9d0bae2b | 1 | 2012-07-24 |
| 51672-4111-3 | EA - Each | 51672-4111 | ce9b3ded-f89d-4b8d-8d40-286c6ac91bdb | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51672-4111 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.] | 15 | Current NDC, Legacy NDC, 5 package rows | 20240929_601f7353-225d-4a5d-9810-3869c2c21874.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Phenytoin Sodium | PHENYTOIN SODIUM | A-S Medication Solutions | ef4e97a7-cd18-47a9-a016-2eca5481a87e | 2026-07-24 | Warnings, Adverse reactions | 040684 ANDA040684 |
| Phenytoin Sodium | PHENYTOIN SODIUM | REMEDYREPACK INC. | e33ce05d-9c60-4ede-8b13-e8c41a3de25d | 2026-05-19 | Warnings, Adverse reactions | 040684 ANDA040684 |
| Phenytoin Sodium | PHENYTOIN SODIUM | Coupler LLC | 51b660c3-7d88-77b2-e063-6294a90a0286 | 2026-05-13 | Warnings, Adverse reactions | 040684 ANDA040684 |
| Phenytoin Sodium | PHENYTOIN SODIUM | Golden State Medical Supply, Inc. | 36262a4c-33f1-40a5-e063-6394a90ad36a | 2026-04-21 | Warnings, Adverse reactions | 040684 ANDA040684 |
| Phenytoin Sodium | PHENYTOIN SODIUM | REMEDYREPACK INC. | 844a16db-17d5-44da-819d-54f3e19cfec2 | 2026-03-25 | Warnings, Adverse reactions | 040684 ANDA040684 |
| Phenytoin Sodium | PHENYTOIN SODIUM | Sun Pharmaceutical Industries, Inc. | 601f7353-225d-4a5d-9810-3869c2c21874 | 2026-03-17 | Warnings, Adverse reactions | 040684 ANDA040684 51672-4111 |
| Phenytoin Sodium | PHENYTOIN SODIUM | AvPAK | 4c2542b8-ac54-e85d-e063-6294a90a759b | 2026-03-03 | Warnings, Adverse reactions | 040684 ANDA040684 |
| Phenytoin Sodium | PHENYTOIN SODIUM | Proficient Rx LP | f4353734-29b0-4027-824d-2fc97f778c67 | 2026-02-01 | Warnings, Adverse reactions | 040684 ANDA040684 |
| Phenytoin Sodium | PHENYTOIN SODIUM | Major Pharmaceuticals | 46d5c0d1-a97b-46d9-8cf4-994780673337 | 2025-12-09 | Warnings, Adverse reactions | 040684 ANDA040684 |
| Phenytoin Sodium | PHENYTOIN SODIUM | Aphena Pharma Solutions - Tennessee, LLC | 3bc82d23-3950-f181-e063-6394a90ad565 | 2025-09-02 | Warnings, Adverse reactions | 040684 ANDA040684 |
| Phenytoin Sodium | PHENYTOIN SODIUM | Aphena Pharma Solutions - Tennessee, LLC | 29b8d0a2-a96e-46a5-e063-6394a90a7113 | 2024-12-20 | Warnings, Adverse reactions | 040684 ANDA040684 |
| Phenytoin Sodium | PHENYTOIN SODIUM | Bryant Ranch Prepack | 6b4c2885-eae0-4c88-ada3-62a699df1dbb | 2024-11-01 | Warnings, Adverse reactions | 040684 ANDA040684 |
| Phenytoin Sodium | PHENYTOIN SODIUM | A-S Medication Solutions | d4459837-da26-4c97-8587-32eb1f682d58 | 2024-05-22 | Warnings, Adverse reactions | 040684 ANDA040684 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | e33ce05d-9c60-4ede-8b13-e8c41a3de25d | 21 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | e33ce05d-9c60-4ede-8b13-e8c41a3de25d | 21 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | e33ce05d-9c60-4ede-8b13-e8c41a3de25d | 21 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | 844a16db-17d5-44da-819d-54f3e19cfec2 | 16 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | 601f7353-225d-4a5d-9810-3869c2c21874 | 16 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | 844a16db-17d5-44da-819d-54f3e19cfec2 | 16 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | 601f7353-225d-4a5d-9810-3869c2c21874 | 16 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | 844a16db-17d5-44da-819d-54f3e19cfec2 | 16 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | 601f7353-225d-4a5d-9810-3869c2c21874 | 16 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | ef4e97a7-cd18-47a9-a016-2eca5481a87e | 8 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | ef4e97a7-cd18-47a9-a016-2eca5481a87e | 8 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | ef4e97a7-cd18-47a9-a016-2eca5481a87e | 8 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | 98a89f5d-edf7-4539-8535-3453a0ccc57f | 3 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | 98a89f5d-edf7-4539-8535-3453a0ccc57f | 3 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | 98a89f5d-edf7-4539-8535-3453a0ccc57f | 3 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | 36262a4c-33f1-40a5-e063-6394a90ad36a | 2 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | 6bdcf521-e68e-4849-bfe2-3d46f038a364 | 2 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | 6794195c-47fa-47e9-9bac-cbbbdfbeef68 | 2 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | 6794195c-47fa-47e9-9bac-cbbbdfbeef68 | 2 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | 6bdcf521-e68e-4849-bfe2-3d46f038a364 | 2 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | 36262a4c-33f1-40a5-e063-6394a90ad36a | 2 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | 6794195c-47fa-47e9-9bac-cbbbdfbeef68 | 2 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | 36262a4c-33f1-40a5-e063-6394a90ad36a | 2 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | 6bdcf521-e68e-4849-bfe2-3d46f038a364 | 2 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | da966d98-94a6-463e-aff7-771406c4c836 | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | b7758662-dcd2-4a02-933f-8a3de70cf551 | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | 51b660c3-7d88-77b2-e063-6294a90a0286 | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | 4c2542b8-ac54-e85d-e063-6294a90a759b | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | 46d5c0d1-a97b-46d9-8cf4-994780673337 | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | f4353734-29b0-4027-824d-2fc97f778c67 | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | PSN | 29b8d0a2-a96e-46a5-e063-6394a90a7113 | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | f4353734-29b0-4027-824d-2fc97f778c67 | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | da966d98-94a6-463e-aff7-771406c4c836 | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | 29b8d0a2-a96e-46a5-e063-6394a90a7113 | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | b7758662-dcd2-4a02-933f-8a3de70cf551 | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | 51b660c3-7d88-77b2-e063-6294a90a0286 | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | 4c2542b8-ac54-e85d-e063-6294a90a759b | 1 |
| 855671 | phenytoin sodium 100 MG Extended Release Oral Capsule | SCD | 46d5c0d1-a97b-46d9-8cf4-994780673337 | 1 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | da966d98-94a6-463e-aff7-771406c4c836 | 1 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | b7758662-dcd2-4a02-933f-8a3de70cf551 | 1 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | 51b660c3-7d88-77b2-e063-6294a90a0286 | 1 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | 4c2542b8-ac54-e85d-e063-6294a90a759b | 1 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | 46d5c0d1-a97b-46d9-8cf4-994780673337 | 1 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | 29b8d0a2-a96e-46a5-e063-6394a90a7113 | 1 |
| 855671 | DPH sodium 100 MG Extended Release Oral Capsule | SY | f4353734-29b0-4027-824d-2fc97f778c67 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51672-4111-0 | 51672411100 | 10 BLISTER PACK in 1 CARTON (51672-4111-0) > 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2006-09-05 | 0000-00-00 | No | No | Current |
| 51672-4111-1 | 51672411101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51672-4111-1) | 2006-09-05 | 0000-00-00 | No | No | Current | |
| 51672-4111-3 | 51672411103 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51672-4111-3) | 2006-09-05 | 0000-00-00 | No | No | Current | |
| 51672-4111-6 | 51672411106 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51672-4111-6) | 2006-09-05 | 0000-00-00 | No | No | Current |