Sevelamer hydrochloride
- Product NDC
- 70748-173
- 11-digit product format
- 707480173
- Labeler code
- 70748
- Product ID
- 70748-173_cc130cfa-f3e5-460d-92a8-69cc0f958dd2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sevelamer hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA213145
- Marketing category
- ANDA
- Marketing start
- 2022-02-25
- Substance
- SEVELAMER HYDROCHLORIDE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sevelamer hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SEVELAMER HYDROCHLORIDE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GLS2PGI8QG |
| Rxcui | 857224 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70748-173-26 | Sevelamer hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70748-173 | SEVELAMER HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20220303_a56c857e-bc39-484c-908d-f5957857efbb.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 |
|---|
| 70748-173-26 | 70748017326 | 180 TABLET in 1 BOTTLE (70748-173-26) | 180 tablet | 2022-02-25 | 0000-00-00 | No | No | Current |