Dantrolene Sodium
- Product NDC
- 0115-4422
- 11-digit product format
- 001154422
- Labeler code
- 0115
- Product ID
- 0115-4422_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
- 50 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 | 50 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 |
|---|
| 0115-4422-01 | Dantrolene Sodium | 100 in 1 BOTTLE | CAPSULE | 100 | | 15 |
| 0115-4422-02 | Dantrolene Sodium | 500 in 1 BOTTLE | CAPSULE | 500 | | 15 |
| 0115-4422-03 | Dantrolene Sodium | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-4422 | 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 |
|---|
| 0115-4422-01 | 00115442201 | 100 CAPSULE in 1 BOTTLE (0115-4422-01) | 100 capsule | 2005-03-01 | 0000-00-00 | No | No | Current |
| 0115-4422-02 | 00115442202 | 500 CAPSULE in 1 BOTTLE (0115-4422-02) | 500 capsule | 2005-03-01 | 0000-00-00 | No | No | Current |
| 0115-4422-03 | 00115442203 | 1000 CAPSULE in 1 BOTTLE (0115-4422-03) | 1000 capsule | 2005-03-01 | 0000-00-00 | No | No | Current |