Raloxifene Hydrochloride

Product NDC: 31722-256
11-digit product format: 317220256
Labeler code: 31722
Product ID: 31722-256_46a8448f-fd60-4043-ae6a-512d67d50cc2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Raloxifene Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Camber Pharmaceuticals Inc
Application: ANDA090842
Marketing category: ANDA
Marketing start: 2014-09-24
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: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	31722-256		D	Discontinued by firm	2026-08-17
excluded package	package	31722-256	31722-256-01	D	Discontinued by firm	2026-08-17
excluded package	package	31722-256	31722-256-10	D	Discontinued by firm	2026-08-17
excluded package	package	31722-256	31722-256-30	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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	31722-256-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	31722-256-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	31722-256-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	31722-256-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	31722-256-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	31722-256-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	31722-256-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	31722-256-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	31722-256-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	31722-256-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	31722-256-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	31722-256-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	31722-256-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	31722-256-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	31722-256-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	31722-256-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	31722-256-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	31722-256-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	31722-256-10	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	31722-256-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	31722-256-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	31722-256-10	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	31722-256-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	31722-256-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	31722-256-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	31722-256-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	31722-256-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	31722-256-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	31722-256-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	31722-256-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	31722-256-10	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	31722-256-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	31722-256-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	31722-256-10	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	31722-256-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	31722-256-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	31722-256-10	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	31722-256-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	31722-256-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	31722-256-10	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	31722-256-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	31722-256-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	31722-256-10	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	31722-256-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	31722-256-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A090842-001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2014-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090842-001	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	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090842-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2014-09-24	`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	A090842-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090842-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090842-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090842-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090842-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090842-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090842-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090842-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090842-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090842-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090842-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090842-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090842-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090842-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090842-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090842-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090842-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090842-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090842-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090842-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090842-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090842-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090842-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090842-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090842-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090842-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090842-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090842-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090842-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090842-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090842-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090842-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090842-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090842-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090842-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090842-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090842-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090842-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090842-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090842-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
31722-256-01	2025-06-17	These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
31722-256-10	2025-06-17	These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
31722-256-30	2025-06-17	These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
31722-256-01	2019-11-27	These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
31722-256-10	2019-11-27	These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
31722-256-30	2019-11-27	These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-256-01	EA - Each	31722-256	01b25acd-0db2-4ac9-9af9-0207af2376da	1	2014-10-03
31722-256-10	EA - Each	31722-256	83e267ab-46bf-4293-a28b-9766a6854a7f	1	2014-10-03
31722-256-30	EA - Each	31722-256	00a536fc-b42f-43f6-b010-804470adfa5a	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RALOXIFENE HYDROCHLORIDE	ACTIVE INGREDIENT	4F86W47BR6	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1
RALOXIFENE	ACTIVE MOIETY	YX9162EO3I	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-256	RALOXIFENE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]	1	Legacy NDC	20140925_8f4fe353-c5de-44ba-9c68-b75a185f7dc5.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Raloxifene Hydrochloride	RALOXIFENE	American Health Packaging	f5c25553-1546-451d-8069-c0f484c47741	2024-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090842 application number: ANDA090842
Raloxifene Hydrochloride	RALOXIFENE	Aphena Pharma Solutions - Tennessee, LLC	53a2db10-4af8-4032-b598-b7c7a0969801	2021-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090842 application number: ANDA090842
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Exelan Pharmaceuticals, Inc.	2b94ecf5-d870-4132-b455-d5ee5c9dce56	2020-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090842 application number: ANDA090842
Raloxifene Hydrochloride	RALOXIFENE	Cipla USA Inc.	8fef5bfd-a786-4442-b09b-f3b81812cdac	2020-09-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090842 application number: ANDA090842

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Raloxifene Hydrochloride	Camber Pharmaceuticals Inc \| InvaGen Pharmaceuticals Inc	2014-09-24	HUMAN PRESCRIPTION DRUG LABEL	1