Risedronate Sodium
- Product NDC
- 60505-3096
- 11-digit product format
- 605053096
- Labeler code
- 60505
- Product ID
- 60505-3096_03750616-5c88-729a-215e-3d796f8ba6a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risedronate Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA090877
- Marketing category
- ANDA
- Marketing start
- 2014-06-11
- Substance
- RISEDRONATE SODIUM
- Active strength
- 75 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 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OFG5EXG60L |
| Rxcui | 905024, 905028, 905083 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-3096-2 | Risedronate Sodium | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | | 15 |
| 60505-3096-2 | Risedronate Sodium | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RISEDRONATE SODIUM ANHYDROUS | ACTIVE INGREDIENT | OFG5EXG60L | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| RISEDRONIC ACID | ACTIVE MOIETY | KM2Z91756Z | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| Crospovidone | INACTIVE INGREDIENT | 68401960MK | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-3096 | RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250411_b90f2e5b-10b8-29a7-0360-31bd0dae0ec2.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 |
|---|
| 60505-3096-2 | 60505309602 | 1 BLISTER PACK in 1 CARTON (60505-3096-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2014-06-11 | 0000-00-00 | No | No | Current |