risedronate sodium
- Product NDC
- 47335-666
- 11-digit product format
- 473350666
- Labeler code
- 47335
- Product ID
- 47335-666_a9910c38-e099-4f8a-a7e9-a88623be2032
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risedronate sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090886
- Marketing category
- ANDA
- Marketing start
- 2015-11-30
- Substance
- RISEDRONATE SODIUM HEMI-PENTAHYDRATE
- Active strength
- 5 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 HEMI-PENTAHYDRATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HU2YAQ274O |
| Rxcui | 905024, 905028, 905032, 905041, 905083, 905092, 905100 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-666-08 | risedronate sodium | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 17 |
| 47335-666-18 | risedronate sodium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 17 |
| 47335-666-83 | risedronate sodium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 17 |
| 47335-666-88 | risedronate sodium | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-666 | RISEDRONATE SODIUM TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 15 | Current NDC, Legacy NDC, 4 package rows | 20240704_e0b5f0ed-ff40-4f0d-bb86-81a7ace9f339.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 |
|---|
| 47335-666-08 | 47335066608 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-666-08) | 2015-11-30 | 0000-00-00 | No | No | Current |
| 47335-666-18 | 47335066618 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-666-18) | 2015-11-30 | 0000-00-00 | No | No | Current |
| 47335-666-83 | 47335066683 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-666-83) | 2015-11-30 | 0000-00-00 | No | No | Current |
| 47335-666-88 | 47335066688 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-666-88) | 2015-11-30 | 0000-00-00 | No | No | Current |