Home NDC 33342-087 Rizatriptan
Product NDC 33342-087
11-digit product format 333420087
Labeler code 33342
Product ID 33342-087_fe80232a-c329-47ed-8edd-7786e06f3c08
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rizatriptan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA203147
Marketing category ANDA
Marketing start 2014-03-11
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 A203147-001 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 A203147-002 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203147-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2014-02-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203147-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2014-02-11 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Rizatriptan
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 33342-087-02 Rizatriptan 6 in 1 BLISTER PACK TABLET, FILM COATED 6 7 33342-087-07 Rizatriptan 30 in 1 CONTAINER TABLET, FILM COATED 30 7 33342-087-12 Rizatriptan 10 in 1 CARTON TABLET, FILM COATED 10 7 33342-087-12 Rizatriptan 10 in 1 BLISTER PACK TABLET, FILM COATED 10 7 33342-087-41 Rizatriptan 3 in 1 CARTON TABLET, FILM COATED 3 7 33342-087-45 Rizatriptan 2 in 1 CARTON TABLET, FILM COATED 2 7 33342-087-46 Rizatriptan 200 in 1 CONTAINER TABLET, FILM COATED 200 7 33342-087-50 Rizatriptan 4 in 1 CARTON TABLET, FILM COATED 4 7 33342-087-52 Rizatriptan 3 in 1 BLISTER PACK TABLET, FILM COATED 3 7 33342-087-72 Rizatriptan 6 in 1 CARTON TABLET, FILM COATED 6 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RIZATRIPTAN BENZOATE ACTIVE INGREDIENT WR978S7QHH RIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 RIZATRIPTAN ACTIVE MOIETY 51086HBW8G RIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 RIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-087 RIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 7 Current NDC, Legacy NDC, 10 package rows 20220703_27bc2cfc-fefb-4b50-a0dc-6268c69b4902.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 · 5 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 33342-087-02 33342008702 6 in 1 BLISTER PACK Historical 33342-087-07 33342008707 30 TABLET, FILM COATED in 1 CONTAINER (33342-087-07) 2014-03-11 0000-00-00 No No Current 33342-087-12 33342008712 10 BLISTER PACK in 1 CARTON (33342-087-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2014-03-11 0000-00-00 No No Current 33342-087-41 33342008741 3 BLISTER PACK in 1 CARTON (33342-087-41) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-087-02) 3 blister pack 2018-09-03 0000-00-00 No No Current 33342-087-45 33342008745 2 BLISTER PACK in 1 CARTON (33342-087-45) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-087-02) 2 blister pack 2018-09-03 0000-00-00 No No Current 33342-087-46 33342008746 200 TABLET, FILM COATED in 1 CONTAINER (33342-087-46) 2014-03-11 0000-00-00 No No Current 33342-087-50 33342008750 4 BLISTER PACK in 1 CARTON (33342-087-50) / 3 TABLET, FILM COATED in 1 BLISTER PACK (33342-087-52) 4 blister pack 2014-03-11 0000-00-00 No No Current 33342-087-52 33342008752 3 in 1 BLISTER PACK Historical 33342-087-72 33342008772 6 BLISTER PACK in 1 CARTON (33342-087-72) / 3 TABLET, FILM COATED in 1 BLISTER PACK (33342-087-52) 6 blister pack 2014-03-11 0000-00-00 No No Current