Raloxifene hydrochloride
- Product NDC
- 71335-1460
- 11-digit product format
- 713351460
- Labeler code
- 71335
- Product ID
- 71335-1460_ce50b6f7-832c-43e5-a1dd-928baedc07f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Raloxifene hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4F86W47BR6 |
| Rxcui | 1490065 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1460-1 | Raloxifene hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
| 71335-1460-2 | Raloxifene hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1460 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230331_ad3ef791-ac90-4f66-8da6-95b31e4c3eb6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1460-1 | 71335146001 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1460-1) | 2020-01-03 | 0000-00-00 | No | No | Current |
| 71335-1460-2 | 71335146002 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1460-2) | 2021-12-28 | 0000-00-00 | No | No | Current |