Risedronate Sodium
- Product NDC
- 33342-109
- 11-digit product format
- 333420109
- Labeler code
- 33342
- Product ID
- 33342-109_56e83e0f-83f7-4039-a9b2-0d5ae251e2b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risedronate Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA203533
- Marketing category
- ANDA
- Marketing start
- 2015-12-09
- Substance
- RISEDRONATE SODIUM
- 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 | 35 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 |
|---|
| 33342-109-37 | Risedronate Sodium | 4 in 1 BLISTER PACK | TABLET, FILM COATED | 4 | | 9 |
| 33342-109-37 | Risedronate Sodium | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 33342-109-50 | Risedronate Sodium | 4 in 1 BLISTER PACK | TABLET, FILM COATED | 4 | | 9 |
| 33342-109-50 | Risedronate Sodium | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-109 | RISEDRONATE SODIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 7 | Current NDC, Legacy NDC, 4 package rows | 20230802_62aff8d6-a2f7-4c7e-a102-c70105ac3792.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 |
|---|
| 33342-109-37 | 33342010937 | 1 BLISTER PACK in 1 CARTON (33342-109-37) / 4 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2015-12-09 | 0000-00-00 | No | No | Current |
| 33342-109-50 | 33342010950 | 3 BLISTER PACK in 1 CARTON (33342-109-50) / 4 TABLET, FILM COATED in 1 BLISTER PACK | 3 blister pack | 2015-12-09 | 0000-00-00 | No | No | Current |