Rocuronium Bromide
- Product NDC
- 42677-310
- 11-digit product format
- 426770310
- Labeler code
- 42677
- Product ID
- 42677-310_51ae72f8-d3d6-71e5-e063-6394a90a640d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rocuronium Bromide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Shandong New Time Pharmaceutical Co., Ltd.
- Application
- ANDA215684
- Marketing category
- ANDA
- Marketing start
- 2024-07-12
- Substance
- ROCURONIUM BROMIDE
- Active strength
- 100 mg/10mL
- Pharmacologic classes
- Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rocuronium Bromide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROCURONIUM BROMIDE | 100 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I65MW4OFHZ |
| Rxcui | 1234995 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42677-310-01 | Rocuronium Bromide | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 2 |
| 42677-310-10 | Rocuronium Bromide | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 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 |
|---|
| 42677-310-01 | 42677031001 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | Historical |
| 42677-310-10 | 42677031010 | 10 VIAL, MULTI-DOSE in 1 CARTON (42677-310-10) / 10 mL in 1 VIAL, MULTI-DOSE (42677-310-01) | | 2024-07-12 | No | No | Historical |