Home NDC 45963-480 Alosetron Hydrochloride
Product NDC 45963-480
11-digit product format 459630480
Labeler code 45963
Product ID 45963-480_963590cd-862a-cf1d-e053-2a95a90af4c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name alosetron hydrochloride
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA021107
Marketing category NDA
Marketing start 2015-05-26
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 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N021107-001 LOTRONEX ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 N021107-002 LOTRONEX ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23
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 · 84 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 2026-08-18 06:07:40 2026-07 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded alosetron hydrochloride ACTIVE INGREDIENT 2F5R1A46YW ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 4 alosetron ACTIVE MOIETY 13Z9HTH115 ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 4 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 4 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 4 indigotindisulfonate sodium INACTIVE INGREDIENT D3741U8K7L ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 4 lactose INACTIVE INGREDIENT J2B2A4N98G ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 4 starch, corn INACTIVE INGREDIENT O8232NY3SJ ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 4 triacetin INACTIVE INGREDIENT XHX3C3X673 ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45963-480 ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 11 Legacy NDC 20241215_969429cb-60b9-4a9c-be60-dd01994431b2.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45963-480-03 45963048003 1 BOTTLE in 1 CARTON (45963-480-03) > 30 TABLET in 1 BOTTLE 1 bottle 2015-05-26 0000-00-00 No No Current