dantrolene sodium
- Product NDC
- 70518-4622
- 11-digit product format
- 705184622
- Labeler code
- 70518
- Product ID
- 70518-4622_5039fd42-8304-4d69-e063-6294a90ab004
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dantrolene sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA017443
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2026-04-24
- 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
- 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 287M0347EV |
| Rxcui | 856652 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4622-0 | dantrolene sodium | 50 in 1 BOX | CAPSULE | 50 | | 1 |
| 70518-4622-1 | dantrolene sodium | 1 in 1 POUCH | CAPSULE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4622-0 | 70518462200 | 50 POUCH in 1 BOX (70518-4622-0) / 1 CAPSULE in 1 POUCH (70518-4622-1) | 50 pouch | 2026-04-24 | No | No | Historical |
| 70518-4622-1 | 70518462201 | 1 in 1 POUCH | | | | | Historical |