risedronate sodium
- Product NDC
- 0591-2044
- 11-digit product format
- 005912044
- Labeler code
- 0591
- Product ID
- 0591-2044_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
- 2014-06-11
- Marketing end
- 2021-09-30
- Substance
- RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
- Active strength
- 129 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 |
|---|
| 0591-2044-03 | 00591204403 | 3 TABLET, FILM COATED in 1 DOSE PACK (0591-2044-03) | 2014-06-11 | 2021-09-30 | No | No | Current |