Home NDC 0378-1403-96 Rizatriptan Benzoate
Product NDC 0378-1403
Requested package NDC 0378-1403-96
11-digit product format 003781403
Labeler code 0378
Product ID 0378-1403_884b2f91-8db1-4ea6-9332-acbae2ef2191
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rizatriptan benzoate
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA201993
Marketing category ANDA
Marketing start 2012-12-31
Marketing end 0000-00-00
Substance RIZATRIPTAN BENZOATE
Active strength 5 mg/1
Pharmacologic classes Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201993-001 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2012-12-31 A201993-002 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2012-12-31
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201993-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201993-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-1403 RIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.] 8 Legacy NDC 20250101_30a602e9-495e-43ae-a4ea-acb564540b25.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-1403-96 00378140396 12 TABLET in 1 BOTTLE, PLASTIC (0378-1403-96) 12 tablet 2012-12-31 0000-00-00 No No Current