Revonto
- Product NDC
- 84549-003
- 11-digit product format
- 845490003
- Labeler code
- 84549
- Product ID
- 84549-003_463e554f-a0fa-ab45-e063-6294a90abcf6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dantrolene sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ProPharma Distribution
- Application
- ANDA078378
- Marketing category
- ANDA
- Marketing start
- 2021-04-09
- Substance
- DANTROLENE SODIUM
- Active strength
- 20 mg/60mL
- 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
- Revonto
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DANTROLENE SODIUM | 20 mg/60mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 287M0347EV |
| Rxcui | 856696, 1012465 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84549-003-67 | Revonto | 60 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 60 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84549-003-67 | 84549000367 | 60 mL in 1 VIAL, GLASS (84549-003-67) | 60 ml | 2025-09-15 | No | No | Current |