Raloxifene hydrochloride
- Product NDC
- 71610-053
- 11-digit product format
- 716100053
- Labeler code
- 71610
- Product ID
- 71610-053_29e0719a-c1c4-429b-8544-f1efe06c33fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Raloxifene hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- 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 |
|---|
| 71610-053-60 | Raloxifene hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-053 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20180503_6fd63a06-5bc5-4c50-9b85-b09c89100b80.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 |
|---|
| 71610-053-60 | 71610005360 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-053-60) | 2018-04-26 | 0000-00-00 | No | No | Current |