Raloxifene Hydrochloride
- Product NDC
- 65862-709
- 11-digit product format
- 658620709
- Labeler code
- 65862
- Product ID
- 65862-709_161df518-c043-4476-968b-d0268ae03fd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Raloxifene Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- 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 |
|---|
| 65862-709-01 | Raloxifene Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 7 |
| 65862-709-03 | Raloxifene Hydrochloride | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 7 |
| 65862-709-10 | Raloxifene Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 7 |
| 65862-709-22 | Raloxifene Hydrochloride | 2000 in 1 BOTTLE | TABLET, FILM COATED | 2000 | | 7 |
| 65862-709-30 | Raloxifene Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
| 65862-709-99 | Raloxifene Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 7 |
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 [AUROBINDO PHARMA LIMITED] | 1 | |
| RALOXIFENE | ACTIVE MOIETY | YX9162EO3I | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-709 | RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 6 package rows | 20240220_e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5.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 |
|---|
| 65862-709-01 | 65862070901 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-709-01) | | 2015-08-28 | 0000-00-00 | No | No | Current |
| 65862-709-03 | 65862070903 | 3 BLISTER PACK in 1 CARTON (65862-709-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-709-10) | 3 blister pack | 2015-08-28 | 0000-00-00 | No | No | Current |
| 65862-709-10 | 65862070910 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 65862-709-22 | 65862070922 | 2000 TABLET, FILM COATED in 1 BOTTLE (65862-709-22) | | 2015-08-28 | 0000-00-00 | No | No | Current |
| 65862-709-30 | 65862070930 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-709-30) | | 2015-08-28 | 0000-00-00 | No | No | Current |
| 65862-709-39 | 65862070939 | 3000 TABLET, FILM COATED in 1 BAG (65862-709-39) | | 28-AUG-15 | | | | Current |
| 65862-709-99 | 65862070999 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-709-99) | | 2015-08-28 | 0000-00-00 | No | No | Current |