alosetron hydrochloride

Product NDC: 64980-454
Requested package NDC: 64980-454-50
11-digit product format: 649800454
Labeler code: 64980
Product ID: 64980-454_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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64980-454	64980-454-50	D	Discontinued by firm		2026-07-31

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.

Application-product, TE code table
Application-product	TE code
A209180-001	AB
A209180-002	AB

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.

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
2026-08-01 22:54:32	2026-06	A209180-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2019-01-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209180-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2019-01-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A209180-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209180-002	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-454-03	EA - Each	64980-454	8b14fb14-2ee3-4b80-ad6b-1f521bb03c2c	1	2019-08-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2F5R1A46YW	ALOSETRON HYDROCHLORIDE	122852-69-1	ALOSETRON HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-454-50	64980045450	500 TABLET in 1 BOTTLE (64980-454-50)	500 tablet	2019-01-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
alosetron hydrochloride	Rising Pharmaceuticals, Inc. \| Cipla Limited- Indore	2020-03-10	Human Prescription Drug Label	3