XIFAXAN
- Product NDC
- 65649-303
- 11-digit product format
- 656490303
- Labeler code
- 65649
- Product ID
- 65649-303_b2e9bb84-e97e-4e7e-8a23-425418b4374d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rifaximin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Salix Pharmaceuticals, Inc.
- Application
- NDA021361
- Marketing category
- NDA
- Marketing start
- 2010-05-01
- Substance
- RIFAXIMIN
- Active strength
- 550 mg/1
- Pharmacologic classes
- Rifamycin Antibacterial [EPC], Rifamycins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- XIFAXAN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RIFAXIMIN | 550 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L36O5T016N |
| Rxcui | 429662, 539789, 856664, 856666 |
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RIFAXIMIN | ACTIVE INGREDIENT | L36O5T016N | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| RIFAXIMIN | ACTIVE MOIETY | L36O5T016N | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| GLYCERYL PALMITOSTEARATE | INACTIVE INGREDIENT | GSY51O183C | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 23 | |
| RIFAXIMIN | ACTIVE INGREDIENT | L36O5T016N | XIFAXAN (RIFAXIMIN) TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| RIFAXIMIN | ACTIVE MOIETY | L36O5T016N | XIFAXAN (RIFAXIMIN) TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65649-303 | XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] | 48 | Current NDC, Legacy NDC, 9 package rows | 20241103_c5e8e2fd-7087-4b78-9181-cc259c0be2f1.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 |
|---|
| 65649-303-01 | 65649030301 | 3 CARTON in 1 TRAY (65649-303-01) / 1 BLISTER PACK in 1 CARTON / 2 TABLET in 1 BLISTER PACK | 3 carton | 2010-05-01 | 0000-00-00 | No | No | Current |
| 65649-303-02 | 65649030302 | 60 TABLET in 1 BOTTLE (65649-303-02) | 60 tablet | 2010-05-01 | 0000-00-00 | No | No | Current |
| 65649-303-03 | 65649030303 | 6 BLISTER PACK in 1 CARTON (65649-303-03) / 10 TABLET in 1 BLISTER PACK | 6 blister pack | 2010-05-01 | 0000-00-00 | No | No | Current |
| 65649-303-04 | 65649030304 | 14 in 1 CARTON | | | | | | Historical |
| 65649-303-05 | 65649030305 | 3 CARTON in 1 TRAY (65649-303-05) / 1 BLISTER PACK in 1 CARTON / 3 TABLET in 1 BLISTER PACK | 3 carton | 2010-05-01 | 0000-00-00 | No | No | Current |