Dantrium
- Product NDC
- 42023-124
- 11-digit product format
- 420230124
- Labeler code
- 42023
- Product ID
- 42023-124_edb780bb-3d09-4f16-9a76-c263f6de8713
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dantrolene sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- NDA017443
- Marketing category
- NDA
- Marketing start
- 2008-08-01
- 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
- Dantrium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DANTROLENE SODIUM | 25 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 287M0347EV |
| Rxcui | 856652, 856654, 856656, 856658, 856660, 856662 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e1aa0c0-7e5b-41f6-80ca-71938bc3ba10 | Product name | 2 | 20170803 |
| d7dbb6a6-7ce7-4878-a62c-772d63bc4c9f | Product name | 2 | 20141210 |
| aa6a0d9e-0b39-aacf-4e4e-ce5e489de585 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42023-124-01 | Dantrium | 100 in 1 BOTTLE | CAPSULE | 100 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42023-124-01 | EA - Each | 42023-124 | 0924187b-5cbf-42c1-8b0c-daa5c056c0aa | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| dantrolene sodium | ACTIVE INGREDIENT | 287M0347EV | DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC] | 6 | |
| dantrolene | ACTIVE MOIETY | F64QU97QCR | DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC] | 6 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC] | 6 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC] | 6 | |
| Lactose | INACTIVE INGREDIENT | J2B2A4N98G | DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC] | 6 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC] | 6 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC] | 6 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC] | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856654 | Dantrium 100 MG Oral Capsule | PSN | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856658 | Dantrium 25 MG Oral Capsule | PSN | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856662 | Dantrium 50 MG Oral Capsule | PSN | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856652 | dantrolene sodium 100 MG Oral Capsule | PSN | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856656 | dantrolene sodium 25 MG Oral Capsule | PSN | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856660 | dantrolene sodium 50 MG Oral Capsule | PSN | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856654 | dantrolene sodium 100 MG Oral Capsule [Dantrium] | SBD | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856658 | dantrolene sodium 25 MG Oral Capsule [Dantrium] | SBD | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856662 | dantrolene sodium 50 MG Oral Capsule [Dantrium] | SBD | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856652 | dantrolene sodium 100 MG Oral Capsule | SCD | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856656 | dantrolene sodium 25 MG Oral Capsule | SCD | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856660 | dantrolene sodium 50 MG Oral Capsule | SCD | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856654 | Dantrium 100 MG Oral Capsule | SY | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856658 | Dantrium 25 MG Oral Capsule | SY | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
| 856662 | Dantrium 50 MG Oral Capsule | SY | 57b4eec1-49e1-432c-95ae-0fe36e32d64b | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42023-124-01 | 42023012401 | 100 CAPSULE in 1 BOTTLE (42023-124-01) | 100 capsule | 2008-08-01 | 0000-00-00 | No | No | Current |