Raloxifene Hydrochloride

Product NDC: 43353-253
11-digit product format: 433530253
Labeler code: 43353
Product ID: 43353-253_293b1286-f467-418f-9b40-e5502c14c3b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Raloxifene Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA204310
Marketing category: ANDA
Marketing start: 2015-08-28
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43353-253		D	Discontinued by firm		2026-08-17
excluded package	package	43353-253	43353-253-60	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 · 4 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	43353-253-60	`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	43353-253-60	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A204310-001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2015-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204310-001	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	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204310-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2015-08-28	`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	A204310-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204310-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204310-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204310-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204310-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204310-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204310-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204310-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204310-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204310-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204310-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204310-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204310-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204310-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204310-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204310-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204310-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204310-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204310-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204310-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204310-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204310-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204310-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204310-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204310-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204310-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204310-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204310-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204310-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204310-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204310-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204310-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204310-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204310-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204310-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204310-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204310-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204310-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204310-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204310-001	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
43353-253-60	EA - Each	43353-253	cf216224-039a-443e-9639-f795cb5ad073	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-253	RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20171005_786f2fa3-5a47-43a7-b4f5-fbb8f4de06fa.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 HYDROCHLORIDE	A-S Medication Solutions	804e873e-f48b-4c25-ad7b-41d44f61bdde	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204310 application number: ANDA204310
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Bryant Ranch Prepack	5a22ae27-1c55-487b-8e93-8ef1cec87065	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204310 application number: ANDA204310
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	NorthStar Rx LLC	0f7d1f81-374f-4ad5-aea0-2f97abbe1dbf	2024-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204310 application number: ANDA204310
Raloxifene Hydrochloride	RALOXIFENE HYDROCHLORIDE	Aurobindo Pharma Limited	e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5	2024-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204310 application number: ANDA204310

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
43353-253-60	43353025360	90 TABLET, FILM COATED in 1 BOTTLE (43353-253-60)	2016-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Raloxifene Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2017-10-04	Human Prescription Drug Label	1