Renagel
- Product NDC
- 17856-0021
- 11-digit product format
- 178560021
- Labeler code
- 17856
- Product ID
- 17856-0021_42719fda-d898-4749-b561-f85a5e54cd06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Renagel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corps
- 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
- E
- Listing certified through
- 2018-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-0021-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-efc3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Renagel safely and effectively. See full prescribing information for Renagel. Renagel (sevelamer hydrochloride) Tablet for Oral use Initial U.S. Approval: 2000 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-0021-2 | Renagel | 1 in 1 POUCH | TABLET | 1 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17856-0021-2 | EA - Each | 17856-0021 | 8f10e02f-f432-488b-b80b-2d809a3ad320 | 1 | 2014-07-02 |
DailyMed Socrata Ingredients#
| 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 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-0021 | RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] | 3 | Legacy NDC, 1 package rows | 20140611_ee835dc1-36b7-4447-a5c6-5ed9e06a839d.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857224 | sevelamer HCl 800 MG Oral Tablet | PSN | ee835dc1-36b7-4447-a5c6-5ed9e06a839d | 3 |
| 857224 | sevelamer hydrochloride 800 MG Oral Tablet | SCD | ee835dc1-36b7-4447-a5c6-5ed9e06a839d | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 17856-0021-2 | 17856002102 | 1 in 1 POUCH | Historical |