sevelamer hydrochloride
- Product NDC
- 55154-2647
- 11-digit product format
- 551542647
- Labeler code
- 55154
- Product ID
- 55154-2647_cd703ad5-7d31-462e-971e-44bd794498ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sevelamer hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- PARENTERAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA204724
- Marketing category
- ANDA
- Marketing start
- 2025-02-25
- Substance
- SEVELAMER HYDROCHLORIDE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- sevelamer hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 55154-2647-0 | sevelamer hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 2 |
| 55154-2647-0 | sevelamer hydrochloride | 10 in 1 BAG | TABLET, FILM COATED | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-2647 | SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 1 | Current NDC, 2 package rows | 20250228_c13532a7-4c56-4084-839d-3dcfd4dc30f8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55154-2647-0 | 55154264700 | 10 BLISTER PACK in 1 BAG (55154-2647-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2025-02-25 | No | No | Historical |