Raloxifene hydrochloride

Product NDC: 50228-306
Requested package NDC: 50228-306-30
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 1.

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 · 41 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
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206384-001	RALOXIFENE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2016-10-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206384-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 50228-306-30 ndc (product): 50228-306 ndc11 (package): 50228030630
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

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

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
50228-306-30	50228030630	30 TABLET, FILM COATED in 1 BOTTLE (50228-306-30)	2016-10-12	0000-00-00	No	No	Current