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
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | 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#
| 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.
| 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 | 206384 ANDA206384 |
| Raloxifene hydrochloride | RALOXIFENE HYDROCHLORIDE | Bryant Ranch Prepack | ad3ef791-ac90-4f66-8da6-95b31e4c3eb6 | 2023-03-30 | Boxed warning, Warnings, Adverse reactions | 206384 ANDA206384 |
| Raloxifene hydrochloride | RALOXIFENE HYDROCHLORIDE | ScieGen Pharmaceuticals Inc | 8152e68b-61a8-4897-8e03-900135b1dbd5 | 2023-01-09 | Boxed warning, Warnings, Adverse reactions | 206384 ANDA206384 50228-306-30 50228-306 50228030630 |
| Raloxifene hydrochloride | RALOXIFENE HYDROCHLORIDE | Dr.Reddys Laboratories Inc | 8f24455c-34dc-4e07-bcd3-24326b9cc377 | 2022-12-23 | Boxed warning, Warnings, Adverse reactions | 206384 ANDA206384 |
| Raloxifene hydrochloride | RALOXIFENE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 6fd63a06-5bc5-4c50-9b85-b09c89100b80 | 2018-04-27 | Boxed warning, Warnings, Adverse reactions | 206384 ANDA206384 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Raloxifene hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RALOXIFENE HYDROCHLORIDE | 60 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4F86W47BR6 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1490065 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8152e68b-61a8-4897-8e03-900135b1dbd5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7ad62b49-6132-2a8c-4edd-73f39b2bf45c | Product name | 6 | 20210312 |
DailyMed Package Descriptions#
| 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#
DailyMed RxNorm Mappings#
| 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 | 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 |