SEVELAMER CARBONATE
- Product NDC
- 64380-881
- 11-digit product format
- 643800881
- Labeler code
- 64380
- Product ID
- 64380-881_f0d25733-65a5-4143-a027-3412ff7a167d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sevelamer carbonate
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA211917
- Marketing category
- ANDA
- Marketing start
- 2024-02-02
- Substance
- SEVELAMER CARBONATE
- Active strength
- 2400 mg/2790mg
- 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 CARBONATE
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| SEVELAMER CARBONATE | 2400 mg/2790mg |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 9YCX42I8IU |
| Rxcui | 861370, 861375 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9YCX42I8IU | SEVELAMER CARBONATE | 845273-93-0 | SEVELAMER CARBONATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64380-881-80 | 64380088180 | 90 PACKET in 1 CARTON (64380-881-80) / 2400 mg in 1 PACKET (64380-881-00) | 90 packet | 2024-02-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SEVELAMER CARBONATE | Strides Pharma Science Limited | 2024-02-23 | HUMAN PRESCRIPTION DRUG LABEL | 6 |