Home NDC 64980-453-03 alosetron hydrochloride
Product NDC 64980-453
Requested package NDC 64980-453-03
11-digit product format 649800453
Labeler code 64980
Product ID 64980-453_485cb247-48d8-4bc3-b16b-a0abadea856b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name alosetron hydrochloride
Dosage form TABLET
Route ORAL
Labeler Rising Pharmaceuticals, Inc.
Application ANDA209180
Marketing category ANDA
Marketing start 2019-01-14
Marketing end 0000-00-00
Substance ALOSETRON HYDROCHLORIDE
Active strength 1 mg/1
Pharmacologic classes Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 A209180-001 ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 A209180-002 ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14
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 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209180-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2019-01-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209180-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2019-01-14 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64980-453-03 64980045303 30 TABLET in 1 BOTTLE (64980-453-03) 30 tablet 2019-01-14 0000-00-00 No No Current