Dantrolene Sodium
- Product NDC
- 64850-841
- 11-digit product format
- 648500841
- Labeler code
- 64850
- Product ID
- 64850-841_e3fc6ec6-cdde-456a-81bd-8ebd07065afc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dantrolene sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Elite Laboratories, Inc.
- Application
- ANDA076686
- Marketing category
- ANDA
- Marketing start
- 2005-10-26
- 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
- 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 | 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 |
|---|
| 64850-841-01 | Dantrolene Sodium | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64850-841 | DANTROLENE SODIUM CAPSULE [ELITE LABORATORIES, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230420_e637fb20-6a17-4522-810a-990bf1409732.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 |
|---|
| 64850-841-01 | 64850084101 | 100 CAPSULE in 1 BOTTLE (64850-841-01) | 100 capsule | 2005-10-26 | 0000-00-00 | No | No | Current |