dantrolene sodium
- Product NDC
- 49884-364
- 11-digit product format
- 498840364
- Labeler code
- 49884
- Product ID
- 49884-364_eaaa53d2-744b-4529-ad62-84ab6b4fdd51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dantrolene sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- NDA017443
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-03-28
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- dantrolene sodium
- Listing expiration
- 2026-12-31
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 |
|---|
| 49884-364-01 | dantrolene sodium | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-364 | DANTROLENE SODIUM CAPSULE [ENDO USA, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250109_11689f56-15e0-4350-b53f-ae96e5994fea.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 |
|---|
| 49884-364-01 | 49884036401 | 100 CAPSULE in 1 BOTTLE (49884-364-01) | 100 capsule | 2016-03-28 | 0000-00-00 | No | No | Current |