Home NDC 68462-465 rizatriptan benzoate
Product NDC 68462-465
11-digit product format 684620465
Labeler code 68462
Product ID 68462-465_c7909d7b-34a6-42b0-ad12-eb25f3ce886e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rizatriptan benzoate
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA201967
Marketing category ANDA
Marketing start 2012-12-31
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 2026-12-31
Current FDA listing Yes 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 A201967-001 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2012-12-31 A201967-002 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 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2012-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2012-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2012-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2012-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2012-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2012-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2012-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2012-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2012-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2012-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2012-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2012-12-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2012-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2012-12-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2012-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2012-12-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2012-12-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2012-12-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2012-12-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2012-12-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201967-001 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 A201967-002 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 A201967-001 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 A201967-002 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 A201967-001 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 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201967-002 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 A201967-001 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 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201967-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2012-12-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201967-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2012-12-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201967-002 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 · 60 observed states.
Additional Listing Data#
Finished product Yes
Brand name base rizatriptan benzoate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIZATRIPTAN BENZOATE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WR978S7QHH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312840 Internal RxNorm lookup 314209 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-465-72 rizatriptan benzoate 1 in 1 POUCH TABLET 1 11 68462-465-72 rizatriptan benzoate 12 in 1 CARTON TABLET 12 11 68462-465-99 rizatriptan benzoate 18 in 1 CARTON TABLET 18 11 68462-465-99 rizatriptan benzoate 1 in 1 POUCH TABLET 1 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RIZATRIPTAN BENZOATE ACTIVE INGREDIENT WR978S7QHH RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 RIZATRIPTAN ACTIVE MOIETY 51086HBW8G RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-465 RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 11 Current NDC, Legacy NDC, 4 package rows 20240104_99c66300-bd75-4b31-9fab-88c6e4b12688.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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68462-465-72 68462046572 12 POUCH in 1 CARTON (68462-465-72) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACK 12 pouch 2012-12-31 0000-00-00 No No Current 68462-465-99 68462046599 18 POUCH in 1 CARTON (68462-465-99) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACK 18 pouch 2012-12-31 0000-00-00 No No Current