Renagel
- Product NDC
- 58468-0021
- 11-digit product format
- 584680021
- Labeler code
- 58468
- Product ID
- 58468-0021_500d269a-adb9-499c-ad8b-d9aaa43e1ba9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sevelamer hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Genzyme Corporation
- Application
- NDA021179
- Marketing category
- NDA
- Marketing start
- 2008-06-06
- Marketing end
- 0000-00-00
- Substance
- SEVELAMER HYDROCHLORIDE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SEVELAMER HYDROCHLORIDE | ACTIVE INGREDIENT | GLS2PGI8QG | RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| SEVELAMER | ACTIVE MOIETY | 941N5DUU5C | RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| SEVELAMER HYDROCHLORIDE | ACTIVE INGREDIENT | GLS2PGI8QG | RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SEVELAMER HYDROCHLORIDE | ACTIVE INGREDIENT | GLS2PGI8QG | RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SEVELAMER | ACTIVE MOIETY | 941N5DUU5C | RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SEVELAMER | ACTIVE MOIETY | 941N5DUU5C | RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYPROMELLOSE 2910 (15 CPS) | INACTIVE INGREDIENT | 36SFW2JZ0W | RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYPROMELLOSE 2910 (5 CPS) | INACTIVE INGREDIENT | R75537T0T4 | RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58468-0021-1 | 58468002101 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58468-0021-1) | 2008-06-06 | 0000-00-00 | No | No | Current |