Rocuronium
- Product NDC
- 65219-442
- 11-digit product format
- 652190442
- Labeler code
- 65219
- Product ID
- 65219-442_31c4c874-3d24-4c86-a301-ee9faf0b5c00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROCURONIUM BROMIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA217472
- Marketing category
- NDA
- Marketing start
- 2023-10-11
- Substance
- ROCURONIUM BROMIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rocuronium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROCURONIUM BROMIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I65MW4OFHZ |
| Rxcui | 2720024, 2720026 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-442-02 | Rocuronium | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 1 |
| 65219-442-05 | Rocuronium | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 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 |
|---|
| 65219-442-02 | 65219044202 | 5 mL in 1 VIAL | 5 ml | | | | Historical |
| 65219-442-05 | 65219044205 | 10 VIAL in 1 TRAY (65219-442-05) / 5 mL in 1 VIAL (65219-442-02) | 10 vial | 2023-10-11 | No | No | Current |