Dantrolene
- Product NDC
- 0143-9297
- 11-digit product format
- 001439297
- Labeler code
- 0143
- Product ID
- 0143-9297_769b1f03-2d55-42b7-b29d-60fb5275a67f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dantrolene
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA204762
- Marketing category
- ANDA
- Marketing start
- 2017-06-19
- Substance
- DANTROLENE SODIUM
- Active strength
- 20 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DANTROLENE SODIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 287M0347EV |
| Rxcui | 856696 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9297-01 | Dantrolene | 1 in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9297 | DANTROLENE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20241220_ab0efc75-0598-4f4e-91ad-6195bb2661fe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0143-9297-01 | 00143929701 | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9297-01) | 2017-06-19 | 0000-00-00 | No | No | Current |