Raloxifene Hydrochloride
- Product NDC
- 0093-7290
- 11-digit product format
- 000937290
- Labeler code
- 0093
- Product ID
- 0093-7290_3641edbc-4bae-45d0-8afb-8db02f401f66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Raloxifene Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA078193
- Marketing category
- ANDA
- Marketing start
- 2014-03-28
- 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 |
|---|
| 0093-7290-01 | Raloxifene Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 11 |
| 0093-7290-56 | Raloxifene Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RALOXIFENE HYDROCHLORIDE | ACTIVE INGREDIENT | 4F86W47BR6 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 3 | |
| RALOXIFENE | ACTIVE MOIETY | YX9162EO3I | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 3 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 3 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 3 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 3 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-7290 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20221019_e6be5b1d-757d-4bab-ad6a-c421960a104d.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 |
|---|
| 0093-7290-01 | 00093729001 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-7290-01) | 2014-03-28 | 0000-00-00 | No | No | Current |
| 0093-7290-56 | 00093729056 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-7290-56) | 2014-03-28 | 0000-00-00 | No | No | Current |