Sevelamer Carbonate
- Product NDC
- 68094-034
- 11-digit product format
- 680940034
- Labeler code
- 68094
- Product ID
- 68094-034_85aed37f-f40b-4b15-92e5-037629c95e65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sevelamer Carbonate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Precision Dose, Inc.
- Application
- ANDA207288
- Marketing category
- ANDA
- Marketing start
- 2021-06-23
- Substance
- SEVELAMER CARBONATE
- 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 Carbonate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SEVELAMER CARBONATE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9YCX42I8IU |
| Rxcui | 749206 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68094-034-59 | Sevelamer Carbonate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 4 |
| 68094-034-64 | Sevelamer Carbonate | 9 in 1 CARTON | TABLET, FILM COATED | 9 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68094-034 | SEVELAMER CARBONATE TABLET, FILM COATED [PRECISION DOSE, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241228_09b5e422-18c9-49dc-be3d-5d24648184af.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 |
|---|
| 68094-034-59 | 68094003459 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68094-034-64 | 68094003464 | 9 BLISTER PACK in 1 CARTON (68094-034-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-034-59) | 9 blister pack | 2021-06-23 | 0000-00-00 | No | No | Current |