Home NDC 68180-561 Extended Phenytoin Sodium
Product NDC 68180-561
11-digit product format 681800561
Labeler code 68180
Product ID 68180-561_2af18311-3d00-4d79-94ba-eb36ff78e916
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Extended Phenytoin Sodium
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA211633
Marketing category ANDA
Marketing start 2020-02-01
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211633-001 EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30
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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2019-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2019-09-30 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211633-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2019-09-30 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-12-13 00:20 UTC 2019-12 A211633-001 AB 1 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A211633-001 AB 1 3f01610625f2…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-561-01 68180056101 100 CAPSULE in 1 BOTTLE (68180-561-01) 100 capsule 2020-02-01 0000-00-00 No No Current 68180-561-03 68180056103 1000 CAPSULE in 1 BOTTLE (68180-561-03) 1000 capsule 2020-02-01 0000-00-00 No No Current