Risedronate Sodium
- Product NDC
- 0093-3098
- 11-digit product format
- 000933098
- Labeler code
- 0093
- Product ID
- 0093-3098_641c2a59-be2b-4246-8990-b7bf563012be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risedronate Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA077132
- Marketing category
- ANDA
- Marketing start
- 2015-06-01
- Substance
- RISEDRONATE SODIUM MONOHYDRATE
- Active strength
- 35 mg/1
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Risedronate Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RISEDRONATE SODIUM MONOHYDRATE | 35 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F67L43UT5C |
| Rxcui | 905024, 905032, 905041, 905092, 905100 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-3098-19 | Risedronate Sodium | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 15 |
| 0093-3098-29 | Risedronate Sodium | 12 in 1 CARTON | TABLET, FILM COATED | 12 | | 15 |
| 0093-3098-44 | Risedronate Sodium | 4 in 1 CARTON | TABLET, FILM COATED | 4 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RISEDRONATE SODIUM MONOHYDRATE | ACTIVE INGREDIENT | F67L43UT5C | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| RISEDRONIC ACID | ACTIVE MOIETY | KM2Z91756Z | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-3098 | RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 13 | Current NDC, Legacy NDC, 3 package rows | 20220330_dddcd321-4d2e-4643-bf3c-7b752b33ba39.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 |
|---|
| 0093-3098-19 | 00093309819 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 0093-3098-29 | 00093309829 | 12 BLISTER PACK in 1 CARTON (0093-3098-29) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) | 12 blister pack | 2015-06-01 | 0000-00-00 | No | No | Current |
| 0093-3098-44 | 00093309844 | 4 BLISTER PACK in 1 CARTON (0093-3098-44) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) | 4 blister pack | 2015-06-01 | 0000-00-00 | No | No | Current |