Risedronate Sodium
- Product NDC
- 65862-518
- 11-digit product format
- 658620518
- Labeler code
- 65862
- Product ID
- 65862-518_9488209f-f3ad-4726-be89-f6a7e59e6885
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risedronate Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA200296
- Marketing category
- ANDA
- Marketing start
- 2015-11-30
- Substance
- RISEDRONATE SODIUM
- Active strength
- 30 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OFG5EXG60L |
| 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 |
|---|
| 65862-518-10 | Risedronate Sodium | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 9 |
| 65862-518-30 | Risedronate Sodium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 65862-518-78 | Risedronate Sodium | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 9 |
| 65862-518-99 | Risedronate Sodium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-518 | RISEDRONATE SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 8 | Current NDC, Legacy NDC, 4 package rows | 20240202_89896dfe-f69d-4cb3-bb71-7a7c611071fa.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 |
|---|
| 65862-518-10 | 65862051810 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 65862-518-30 | 65862051830 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-518-30) | | 2015-11-30 | 0000-00-00 | No | No | Current |
| 65862-518-78 | 65862051878 | 10 BLISTER PACK in 1 CARTON (65862-518-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-518-10) | 10 blister pack | 2015-11-30 | 0000-00-00 | No | No | Current |
| 65862-518-99 | 65862051899 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-518-99) | | 2015-11-30 | 0000-00-00 | No | No | Current |