Raloxifene Hydrochloride
- Product NDC
- 50268-694
- 11-digit product format
- 502680694
- Labeler code
- 50268
- Product ID
- 50268-694_48255cf3-7607-03f0-e063-6394a90ae486
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Raloxifene Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA208206
- Marketing category
- ANDA
- Marketing start
- 2018-06-27
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Raloxifene Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RALOXIFENE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4F86W47BR6 |
| Rxcui | 1490065 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50268-694-15 | 2022-02-01 | C162847 | 48780-1 | d6a99b39-36d4-a426-e053-dadaa90af4c2 | Raloxifene HCl Tablets, USP Rx Only These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS, safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 |
| 50268-694-15 | 2022-02-01 | C162847 | 48780-1 | d6a99b39-36d4-a426-e053-dadaa90af4c2 | Raloxifene HCl Tablets, USP Rx Only These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS, safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 |
| 50268-694-15 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-36d4-a426-e053-dadaa90af4c2 | Raloxifene HCl Tablets, USP Rx Only These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS, safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 |
| 50268-694-15 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-36d4-a426-e053-dadaa90af4c2 | Raloxifene HCl Tablets, USP Rx Only These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS, safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-694-11 | Raloxifene Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 6 |
| 50268-694-15 | Raloxifene Hydrochloride | 50 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 50 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-694 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AVPAK] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240110_6f7eb934-aa60-51e1-e053-2a91aa0a3914.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50268-694-11 | 50268069411 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-694-15 | 50268069415 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-694-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-694-11) | 50 blister pack | 2018-06-27 | 0000-00-00 | No | No | Current |