Renagel
- Product NDC
- 58468-0020
- 11-digit product format
- 584680020
- Labeler code
- 58468
- Product ID
- 58468-0020_62a626e6-c535-4eb5-af9e-4dd5baac8e6a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Renagel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Genzyme Corporation
- Application
- NDA021179
- Marketing category
- NDA
- Marketing start
- 2008-06-06
- Marketing end
- 2020-03-01
- Substance
- SEVELAMER HYDROCHLORIDE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5085f16b-f856-182d-a646-425b62d3f565 | Product name | 6 | 20251118 |
| 86e7ef73-ca63-701e-e952-6c80aa5122b8 | Product name | 9 | 20210309 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58468-0020-1 | EA - Each | 58468-0020 | 542a8fac-6415-48e5-99cb-4b81f6878fd2 | 1 | 2012-07-24 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857218 | RenaGel 400 MG Oral Tablet | PSN | 9281598e-60de-4f4f-8e01-0a7dfef92dd3 | 3 |
| 857216 | sevelamer HCl 400 MG Oral Tablet | PSN | 9281598e-60de-4f4f-8e01-0a7dfef92dd3 | 3 |
| 857218 | sevelamer hydrochloride 400 MG Oral Tablet [RenaGel] | SBD | 9281598e-60de-4f4f-8e01-0a7dfef92dd3 | 3 |
| 857216 | sevelamer hydrochloride 400 MG Oral Tablet | SCD | 9281598e-60de-4f4f-8e01-0a7dfef92dd3 | 3 |
| 857218 | RenaGel 400 MG Oral Tablet | SY | 9281598e-60de-4f4f-8e01-0a7dfef92dd3 | 3 |