Raloxifene hydrochloride
- Product NDC
- 0904-6902
- 11-digit product format
- 009046902
- Labeler code
- 0904
- Product ID
- 0904-6902_ae852e8a-bdc7-4062-8939-d5c58768e2bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Raloxifene hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- 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 |
|---|
| 0904-6902-04 | Raloxifene hydrochloride | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 5 |
| 0904-6902-04 | Raloxifene hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6902 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250402_e2967d3c-238c-40cf-b3d8-89482a502928.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 |
|---|
| 0904-6902-04 | 00904690204 | 30 BLISTER PACK in 1 CARTON (0904-6902-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2016-10-12 | 0000-00-00 | No | No | Current |