Relistor
- Product NDC
- 65649-150
- 11-digit product format
- 656490150
- Labeler code
- 65649
- Product ID
- 65649-150_9db15b8c-2928-4b75-a33b-548416afc8c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylnaltrexone bromide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Salix Pharmaceuticals, Inc.
- Application
- NDA208271
- Marketing category
- NDA
- Marketing start
- 2008-08-01
- Substance
- METHYLNALTREXONE BROMIDE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Relistor
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLNALTREXONE BROMIDE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RFO6IL3D3M |
| Rxcui | 979113, 979115, 1244060, 1244062, 1244063, 1244064, 1801514, 1801519 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ISOPROPYL ALCOHOL | ACTIVE INGREDIENT | ND2M416302 | RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.] | 42 | |
| METHYLNALTREXONE BROMIDE | ACTIVE INGREDIENT | RFO6IL3D3M | RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.] | 42 | |
| ISOPROPYL ALCOHOL | ACTIVE MOIETY | ND2M416302 | RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.] | 42 | |
| METHYLNALTREXONE | ACTIVE MOIETY | 0RK7M7IABE | RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.] | 42 | |
| EDETATE CALCIUM DISODIUM | INACTIVE INGREDIENT | 25IH6R4SGF | RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.] | 42 | |
| GLYCINE HYDROCHLORIDE | INACTIVE INGREDIENT | 225ZLC74HX | RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.] | 42 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.] | 42 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | RELISTOR (METHYLNALTREXONE BROMIDE) KIT RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.] | 42 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65649-150 | RELISTOR (METHYLNALTREXONE BROMIDE) TABLET RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.] | 66 | Current NDC, Legacy NDC, 4 package rows | 20240516_c488fb7c-0a5b-487c-b452-996809d1cb99.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 |
|---|
| 65649-150-06 | 65649015006 | 1 BOTTLE in 1 CARTON (65649-150-06) / 6 TABLET in 1 BOTTLE | 1 bottle | 2016-07-19 | 0000-00-00 | No | No | Current |
| 65649-150-60 | 65649015060 | 60 in 1 BOTTLE | | | | | | Historical |
| 65649-150-90 | 65649015090 | 90 TABLET in 1 BOTTLE (65649-150-90) | 90 tablet | 2016-07-19 | 0000-00-00 | No | No | Current |