Raloxifene Hydrochloride
- Product NDC
- 16714-213
- 11-digit product format
- 167140213
- Labeler code
- 16714
- Product ID
- 16714-213_145e48c3-0ef5-41f7-adc2-ab0a7ca89d87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Raloxifene Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA204310
- Marketing category
- ANDA
- Marketing start
- 2015-08-28
- 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 |
|---|
| 16714-213-01 | Raloxifene Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 16714-213-02 | Raloxifene Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 16714-213-03 | Raloxifene Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-213 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 3 | Current NDC, Legacy NDC, 3 package rows | 20240220_0f7d1f81-374f-4ad5-aea0-2f97abbe1dbf.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 |
|---|
| 16714-213-01 | 16714021301 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-213-01) | 2015-08-28 | 0000-00-00 | No | No | Current |
| 16714-213-02 | 16714021302 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-213-02) | 2015-08-28 | 0000-00-00 | No | No | Current |
| 16714-213-03 | 16714021303 | 1000 TABLET, FILM COATED in 1 BOTTLE (16714-213-03) | 2015-08-28 | 0000-00-00 | No | No | Current |