Sevelamer Hydrochloride
- Product NDC
- 33342-241
- 11-digit product format
- 333420241
- Labeler code
- 33342
- Product ID
- 33342-241_6926ebbe-2d74-4d5f-b642-c1bfe3a4e305
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sevelamer Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA206883
- Marketing category
- ANDA
- Marketing start
- 2023-05-26
- Substance
- SEVELAMER HYDROCHLORIDE
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GLS2PGI8QG |
| Rxcui | 857216, 857224 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-241-65 | Sevelamer Hydrochloride | 360 in 1 BOTTLE | TABLET, FILM COATED | 360 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-241 | SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 1 package rows | 20230606_6926ebbe-2d74-4d5f-b642-c1bfe3a4e305.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-241-65 | 33342024165 | 360 TABLET, FILM COATED in 1 BOTTLE (33342-241-65) | 2023-05-26 | No | No | Current |