Rocuronium Bromide
- Product NDC
- 71839-141
- 11-digit product format
- 718390141
- Labeler code
- 71839
- Product ID
- 71839-141_1543ea2b-54ab-4088-a72a-5d71854a2dce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rocuronium bromide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BE Pharmaceuticals Inc.
- Application
- ANDA216234
- Marketing category
- ANDA
- Marketing start
- 2023-07-12
- 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 |
|---|
| 71839-141-01 | Rocuronium Bromide | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 1 |
| 71839-141-10 | 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 |
|---|
| 71839-141 | ROCURONIUM BROMIDE INJECTION, SOLUTION [BE PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20230713_1543ea2b-54ab-4088-a72a-5d71854a2dce.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 |
|---|
| 71839-141-01 | 71839014101 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | | | | Historical |
| 71839-141-10 | 71839014110 | 10 VIAL, MULTI-DOSE in 1 CARTON (71839-141-10) / 5 mL in 1 VIAL, MULTI-DOSE (71839-141-01) | | 2023-07-12 | No | No | Current |