Raloxifene hydrochloride

Product NDC: 50228-306
11-digit product format: 502280306
Labeler code: 50228
Product ID: 50228-306_f1da5bd3-72c2-15ff-e053-2995a90a89db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Raloxifene hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ScieGen Pharmaceuticals Inc
Application: ANDA206384
Marketing category: ANDA
Marketing start: 2016-10-12
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: 2026-12-31
Current FDA listing: Yes

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
A206384-001	RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB		2016-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206384-001	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	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`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	A206384-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206384-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206384-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206384-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206384-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206384-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206384-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206384-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206384-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206384-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206384-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206384-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206384-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206384-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206384-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206384-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206384-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206384-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206384-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206384-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206384-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206384-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206384-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206384-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206384-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206384-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206384-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206384-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206384-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206384-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206384-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206384-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206384-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206384-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206384-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206384-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206384-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206384-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206384-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206384-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Raloxifene hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RALOXIFENE HYDROCHLORIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4F86W47BR6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1490065	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8152e68b-61a8-4897-8e03-900135b1dbd5	Available on FDA.report

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	Strength	SPL version
50228-306-20	Raloxifene hydrochloride	2000 in 1 BOTTLE	TABLET, FILM COATED	2000		3
50228-306-30	Raloxifene hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50228-306	RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC]	3	Current NDC, Legacy NDC, 2 package rows	20230110_8152e68b-61a8-4897-8e03-900135b1dbd5.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Major Pharmaceuticals	e2967d3c-238c-40cf-b3d8-89482a502928	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206384 application number: ANDA206384
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Bryant Ranch Prepack	ad3ef791-ac90-4f66-8da6-95b31e4c3eb6	2023-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206384 application number: ANDA206384
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	ScieGen Pharmaceuticals Inc	8152e68b-61a8-4897-8e03-900135b1dbd5	2023-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206384 application number: ANDA206384 ndc (product): 50228-306
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Dr.Reddys Laboratories Inc	8f24455c-34dc-4e07-bcd3-24326b9cc377	2022-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206384 application number: ANDA206384
Raloxifene hydrochloride	RALOXIFENE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	6fd63a06-5bc5-4c50-9b85-b09c89100b80	2018-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206384 application number: ANDA206384

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	8152e68b-61a8-4897-8e03-900135b1dbd5	3
1490065	raloxifene hydrochloride 60 MG Oral Tablet	SCD	8152e68b-61a8-4897-8e03-900135b1dbd5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50228-306-20	50228030620	2000 TABLET, FILM COATED in 1 BOTTLE (50228-306-20)	2016-10-12	0000-00-00	No	No	Current
50228-306-30	50228030630	30 TABLET, FILM COATED in 1 BOTTLE (50228-306-30)	2016-10-12	0000-00-00	No	No	Current