Risedronate Sodium
- Product NDC
- 65862-870
- 11-digit product format
- 658620870
- Labeler code
- 65862
- Product ID
- 65862-870_bb13e9ba-84fc-41b6-b2f9-bedd9f3eef1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risedronate Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA206768
- Marketing category
- ANDA
- Marketing start
- 2016-10-21
- Substance
- RISEDRONATE SODIUM
- Active strength
- 150 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OFG5EXG60L |
| Rxcui | 905028 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-870-03 | Risedronate Sodium | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | | 8 |
| 65862-870-03 | Risedronate Sodium | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
| 65862-870-11 | Risedronate Sodium | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 8 |
| 65862-870-11 | Risedronate Sodium | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-870 | RISEDRONATE SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 4 package rows | 20240216_a42a35e6-3e08-4b4f-ae56-47d4aec2322a.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 |
|---|
| 65862-870-03 | 65862087003 | 1 BLISTER PACK in 1 CARTON (65862-870-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2016-10-21 | 0000-00-00 | No | No | Current |
| 65862-870-11 | 65862087011 | 1 BLISTER PACK in 1 CARTON (65862-870-11) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2016-10-21 | 0000-00-00 | No | No | Current |