Relistor
- Product NDC
- 65649-551
- 11-digit product format
- 656490551
- Labeler code
- 65649
- Product ID
- 65649-551_9db15b8c-2928-4b75-a33b-548416afc8c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylnaltrexone bromide
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Salix Pharmaceuticals, Inc.
- Application
- NDA021964
- Marketing category
- NDA
- Marketing start
- 2008-04-24
- Substance
- METHYLNALTREXONE BROMIDE
- Active strength
- 12 mg/.6mL
- 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 | 12 mg/.6mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RFO6IL3D3M |
| Rxcui | 979113, 979115, 1244060, 1244062, 1244063, 1244064, 1801514, 1801519 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65649-551-02 | Relistor | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 68 |
| 65649-551-02 | Relistor | 0.6 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 0.6 | | 68 |
| 65649-551-03 | Relistor | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 68 |
| 65649-551-03 | Relistor | 7 in 1 CARTON | INJECTION, SOLUTION | 7 | | 68 |
| 65649-551-07 | Relistor | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 68 |
| 65649-551-07 | Relistor | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 68 |
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 |
|---|
| 65649-551 | RELISTOR (METHYLNALTREXONE BROMIDE) TABLET RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.] | 66 | Current NDC, Legacy NDC, 6 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 |
|---|
| 65649-551-02 | 65649055102 | 1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE | | 2008-04-24 | 0000-00-00 | No | No | Current |
| 65649-551-03 | 65649055103 | 7 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE | 7 blister pack | 2008-04-24 | 0000-00-00 | No | No | Current |
| 65649-551-07 | 65649055107 | 1 BLISTER PACK in 1 CARTON (65649-551-07) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE | 1 blister pack | 2008-04-24 | 0000-00-00 | No | No | Current |