RISEDRONATE SODIUM
- Product NDC
- 63304-440
- 11-digit product format
- 633040440
- Labeler code
- 63304
- Product ID
- 63304-440_d97c9e6a-01e9-46ae-9088-0ca86b4eb842
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RISEDRONATE SODIUM
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industires Inc.
- Application
- ANDA203925
- Marketing category
- ANDA
- Marketing start
- 2019-07-10
- Substance
- RISEDRONATE SODIUM
- Active strength
- 35 mg/1
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RISEDRONATE SODIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RISEDRONATE SODIUM | 35 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OFG5EXG60L |
| Rxcui | 1020064, 1020065 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-440-09 | RISEDRONATE SODIUM | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | | 4 |
| 63304-440-11 | RISEDRONATE SODIUM | 4 in 1 DOSE PACK | TABLET, DELAYED RELEASE | 4 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-440 | RISEDRONATE SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTIRES INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20200910_1d9e520b-2fa6-4603-b397-f0fc24fae775.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 |
|---|
| 63304-440-09 | 63304044009 | 1 DOSE PACK in 1 CARTON (63304-440-09) / 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (63304-440-11) | 1 dose pack | 2019-07-10 | 0000-00-00 | No | No | Current |
| 63304-440-11 | 63304044011 | 4 in 1 DOSE PACK | | | | | | Historical |