Dantrolene Sodium
- Product NDC
- 0115-4433
- 11-digit product format
- 001154433
- Labeler code
- 0115
- Product ID
- 0115-4433_cb60e722-85d9-47a5-8713-e93100343155
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dantrolene Sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA076856
- Marketing category
- ANDA
- Marketing start
- 2005-03-01
- Substance
- DANTROLENE SODIUM
- Active strength
- 100 mg/1
- Pharmacologic classes
- Decreased Striated Muscle Contraction [PE], Decreased Striated Muscle Tone [PE], Skeletal Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dantrolene Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DANTROLENE SODIUM | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 287M0347EV |
| Rxcui | 856652, 856656, 856660 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-4433-01 | Dantrolene Sodium | 100 in 1 BOTTLE | CAPSULE | 100 | | 15 |
| 0115-4433-02 | Dantrolene Sodium | 500 in 1 BOTTLE | CAPSULE | 500 | | 15 |
| 0115-4433-03 | Dantrolene Sodium | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Dantrolene Sodium | ACTIVE INGREDIENT | 287M0347EV | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| DANTROLENE | ACTIVE MOIETY | F64QU97QCR | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DANTROLENE SODIUM CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-4433 | DANTROLENE SODIUM CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 14 | Current NDC, Legacy NDC, 3 package rows | 20231231_c3c45b27-f786-456e-95d6-2e38ef36190a.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 |
|---|
| 0115-4433-01 | 00115443301 | 100 CAPSULE in 1 BOTTLE (0115-4433-01) | 100 capsule | 2005-03-01 | 0000-00-00 | No | No | Current |
| 0115-4433-02 | 00115443302 | 500 CAPSULE in 1 BOTTLE (0115-4433-02) | 500 capsule | 2005-03-01 | 0000-00-00 | No | No | Current |
| 0115-4433-03 | 00115443303 | 1000 CAPSULE in 1 BOTTLE (0115-4433-03) | 1000 capsule | 2005-03-01 | 0000-00-00 | No | No | Current |