RYANODEX
- Product NDC
- 42367-540
- 11-digit product format
- 423670540
- Labeler code
- 42367
- Product ID
- 42367-540_2489f99a-e34f-4773-be47-35ebb68cabfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dantrolene sodium
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Eagle Pharmaceuticals, Inc.
- Application
- NDA205579
- Marketing category
- NDA
- Marketing start
- 2014-07-23
- Substance
- DANTROLENE SODIUM
- Active strength
- 250 mg/5mL
- 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
- RYANODEX
- Brand name suffix
- dantrolene sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DANTROLENE SODIUM | 250 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 287M0347EV |
| Rxcui | 1544753, 1544758 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42367-540-32 | RYANODEX dantrolene sodium | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 10 |
| 42367-540-32 | RYANODEX dantrolene sodium | 20 mL in 1 VIAL | INJECTION, SUSPENSION | 20 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42367-540 | RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) INJECTION, SUSPENSION [EAGLE PHARMACEUTICALS, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241101_8f7b3ac0-604d-4c78-b545-5e0f8ea3d698.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 |
|---|
| 42367-540-32 | 42367054032 | 1 VIAL in 1 CARTON (42367-540-32) / 20 mL in 1 VIAL | 1 vial | 2014-07-23 | 0000-00-00 | No | No | Current |