Sevelamer Hydrochloride
- Product NDC
- 0955-1048
- 11-digit product format
- 009551048
- Labeler code
- 0955
- Product ID
- 0955-1048_b5d5e078-07d1-41bd-90ae-581497782412
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sevelamer Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Winthrop U.S, a business of sanofi-aventis U.S. LLC
- Application
- NDA021179
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-02-13
- Marketing end
- 0000-00-00
- Substance
- SEVELAMER HYDROCHLORIDE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0955-1048 | SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [WINTHROP U.S.] | 16 | Legacy NDC | 20240731_5a76bd76-a6cc-46f1-bb58-660566eaec06.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0955-1048-18 | 00955104818 | 180 TABLET, FILM COATED in 1 BOTTLE (0955-1048-18) | 2019-02-13 | 0000-00-00 | No | No | Current |