risedronate sodium
- Product NDC
- 0591-2075
- 11-digit product format
- 005912075
- Labeler code
- 0591
- Product ID
- 0591-2075_3eedc23c-7012-4057-b5b2-0bf4c2850b6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risedronate sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA020835
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-06-27
- Marketing end
- 2021-05-31
- Substance
- RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
- Active strength
- 30 mg/1; mg/1
- Pharmacologic classes
- Bisphosphonate [EPC],Diphosphonates [CS],Bisphosphonate [EPC],Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2075-04 | 00591207504 | 4 TABLET, FILM COATED in 1 DOSE PACK (0591-2075-04) | 2014-06-27 | 2021-05-31 | No | No | Current |
| 0591-2075-39 | 00591207539 | 12 TABLET, FILM COATED in 1 DOSE PACK (0591-2075-39) | 2014-06-27 | 2021-05-31 | No | No | Current |