Dantrolene Sodium
- Product NDC
- 0904-7211
- 11-digit product format
- 009047211
- Labeler code
- 0904
- Product ID
- 0904-7211_0230882a-a962-4dda-8249-ce0461598764
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dantrolene Sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA076856
- Marketing category
- ANDA
- Marketing start
- 2005-03-01
- Substance
- DANTROLENE SODIUM
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 287M0347EV |
| Rxcui | 856656 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7211-04 | Dantrolene Sodium | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 4 |
| 0904-7211-04 | Dantrolene Sodium | 30 in 1 CARTON | CAPSULE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7211 | DANTROLENE SODIUM CAPSULE [MAJOR PHARMACEUTICALS] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241020_90414d2f-7b2c-47f9-a096-2e7b7dd052de.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 |
|---|
| 0904-7211-04 | 00904721104 | 30 BLISTER PACK in 1 CARTON (0904-7211-04) / 1 CAPSULE in 1 BLISTER PACK | 30 blister pack | 2022-06-20 | 0000-00-00 | No | No | Current |