Raloxifene Hydrochloride

Product NDC: 42291-726
11-digit product format: 422910726
Labeler code: 42291
Product ID: 42291-726_d5bfa252-db5b-6955-e053-2995a90a6012
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Raloxifene Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA078193
Marketing category: ANDA
Marketing start: 2014-11-03
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: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42291-726		D	Discontinued by firm	2026-08-17
excluded package	package	42291-726	42291-726-10	D	Discontinued by firm	2026-08-17
excluded package	package	42291-726	42291-726-90	D	Discontinued by firm	2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-726-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-726-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-726-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-726-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-726-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-726-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-726-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-726-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-726-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-726-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-726-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-726-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-726-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-726-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-726-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-726-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-726-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-726-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-726-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-726-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-726-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-726-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-726-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-726-90	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078193-001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2014-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078193-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078193-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-03-04	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078193-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078193-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078193-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078193-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078193-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078193-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078193-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078193-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078193-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078193-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078193-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078193-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078193-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078193-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078193-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078193-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078193-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078193-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078193-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078193-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078193-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078193-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078193-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078193-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078193-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078193-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078193-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078193-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078193-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078193-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078193-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078193-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078193-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078193-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078193-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078193-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078193-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078193-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078193-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078193-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-726-10	EA - Each	42291-726	aaf4be36-a9e5-402d-933b-6d5d013a7b59	1	2014-12-01
42291-726-90	EA - Each	42291-726	987a6115-5965-4bcf-9503-34cf5868d6b5	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RALOXIFENE HYDROCHLORIDE	ACTIVE INGREDIENT	4F86W47BR6	RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	2
RALOXIFENE	ACTIVE MOIETY	YX9162EO3I	RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	2
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	2
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RALOXIFENE HYDROCHLORIDE (RALOXIFENE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	2

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Bryant Ranch Prepack	3568ed3c-6afd-4872-a861-93a7873bec9c	2023-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078193 application number: ANDA078193
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	e6be5b1d-757d-4bab-ad6a-c421960a104d	2021-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078193 application number: ANDA078193

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-726-10	42291072610	1000 TABLET, FILM COATED in 1 BOTTLE (42291-726-10)	2014-11-03	0000-00-00	No	No	Current