Dantrolene Sodium
- Product NDC
- 68084-300
- 11-digit product format
- 680840300
- Labeler code
- 68084
- Product ID
- 68084-300_259da864-9b15-9e66-e063-6294a90a9b4b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dantrolene Sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA076856
- Marketing category
- ANDA
- Marketing start
- 2008-09-29
- 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
- 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 | 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 |
|---|
| 68084-300-11 | Dantrolene Sodium | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 9 |
| 68084-300-21 | Dantrolene Sodium | 30 in 1 BOX, UNIT-DOSE | CAPSULE | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-300 | DANTROLENE SODIUM CAPSULE [AMERICAN HEALTH PACKAGING] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241031_5162f162-8454-4c07-9670-682df7c30b0f.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 |
|---|
| 68084-300-11 | 68084030011 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68084-300-21 | 68084030021 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-300-21) / 1 CAPSULE in 1 BLISTER PACK (68084-300-11) | 30 blister pack | 2008-09-29 | 0000-00-00 | No | No | Current |