Sevelamer Hydrochloride
- Product NDC
- 60687-449
- 11-digit product format
- 606870449
- Labeler code
- 60687
- Product ID
- 60687-449_26408f23-0427-1bed-e063-6394a90aa7c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sevelamer Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA204724
- Marketing category
- ANDA
- Marketing start
- 2020-01-22
- 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 |
|---|
| 60687-449-01 | Sevelamer Hydrochloride | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 4 |
| 60687-449-11 | Sevelamer Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-449 | SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241108_8830526f-d957-423e-84ea-e4d79346948b.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 |
|---|
| 60687-449-01 | 60687044901 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-449-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-449-11) | 100 blister pack | 2020-01-22 | 0000-00-00 | No | No | Current |
| 60687-449-11 | 60687044911 | 1 in 1 BLISTER PACK | | | | | | Historical |