raloxifene hydrochloride

Product NDC: 68462-393
11-digit product format: 684620393
Labeler code: 68462
Product ID: 68462-393_65356fce-3a04-456a-bd68-88578c47c307
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: raloxifene hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA204491
Marketing category: ANDA
Marketing start: 2016-03-22
Marketing end: 0000-00-00
Substance: RALOXIFENE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68462-393		D	Discontinued by firm	2026-10-15
excluded package	package	68462-393	68462-393-01	D	Discontinued by firm	2026-10-15
excluded package	package	68462-393	68462-393-10	D	Discontinued by firm	2026-10-15
excluded package	package	68462-393	68462-393-23	D	Discontinued by firm	2026-10-15
excluded package	package	68462-393	68462-393-30	D	Discontinued by firm	2026-10-15
excluded package	package	68462-393	68462-393-90	D	Discontinued by firm	2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	68462-393-30
excluded package	package	68462-393-01
excluded package	package	68462-393-23
excluded package	package	68462-393-10
excluded package	package	68462-393-90

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204491-001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2016-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A204491-001	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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204491-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-03-22	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A204491-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204491-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204491-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204491-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7ad62b49-6132-2a8c-4edd-73f39b2bf45c	Product name	6	20210312

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68462-393-01	raloxifene hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	7
68462-393-10	raloxifene hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	7
68462-393-23	raloxifene hydrochloride	2000 in 1 BOTTLE	TABLET, FILM COATED	2000	7
68462-393-30	raloxifene hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
68462-393-90	raloxifene hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-393-01	EA - Each	68462-393	03418256-b780-402b-9d24-200bf413a3ca	1	2016-05-16
68462-393-30	EA - Each	68462-393	9760717c-81c4-4ba9-8d61-c48e7cbea87c	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-393	RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7	Legacy NDC, 5 package rows	20241207_c05521f8-95d2-44b8-8433-eba539c0f84c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4F86W47BR6	RALOXIFENE HYDROCHLORIDE	82640-04-8	RALOXIFENE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1490065	raloxifene HCl 60 MG Oral Tablet	PSN	c05521f8-95d2-44b8-8433-eba539c0f84c	7
1490065	raloxifene hydrochloride 60 MG Oral Tablet	SCD	c05521f8-95d2-44b8-8433-eba539c0f84c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68462-393-01	68462039301	100 in 1 BOTTLE	Historical
68462-393-10	68462039310	1000 in 1 BOTTLE	Historical
68462-393-23	68462039323	2000 in 1 BOTTLE	Historical
68462-393-30	68462039330	30 in 1 BOTTLE	Historical
68462-393-90	68462039390	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
raloxifene hydrochloride	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2024-05-16	HUMAN PRESCRIPTION DRUG LABEL	7