rocuronium bromide
- Product NDC
- 0409-3189
- 11-digit product format
- 004093189
- Labeler code
- 0409
- Product ID
- 0409-3189_c96726ef-f1fa-4ebb-ba33-3479c3902a8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rocuronium bromide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA205656
- Marketing category
- ANDA
- Marketing start
- 2023-07-17
- 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 bromide
- 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 | 1234995 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-3189-05 | rocuronium bromide | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 1 |
| 0409-3189-10 | rocuronium bromide | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-3189 | ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | Current NDC, 2 package rows | 20230717_c96726ef-f1fa-4ebb-ba33-3479c3902a8e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0409-3189-05 | 00409318905 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | | | | Historical |
| 0409-3189-10 | 00409318910 | 10 VIAL, MULTI-DOSE in 1 CARTON (0409-3189-10) / 5 mL in 1 VIAL, MULTI-DOSE (0409-3189-05) | | 2023-07-17 | No | No | Current |