Rocuronium Bromide
- Product NDC
- 71288-718
- 11-digit product format
- 712880718
- Labeler code
- 71288
- Product ID
- 71288-718_37295b13-65a4-40fa-8d6c-53aeb45e2939
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rocuronium Bromide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA213453
- Marketing category
- ANDA
- Marketing start
- 2023-05-08
- 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 |
|---|
| 71288-718-10 | Rocuronium Bromide | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 6 |
| 71288-718-11 | Rocuronium Bromide | 10 in 1 CARTON | INJECTION | 10 | | 6 |
| 71288-718-91 | Rocuronium Bromide | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 1 |
| 71288-718-92 | Rocuronium Bromide | 10 in 1 CARTON | INJECTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-718 | ROCURONIUM BROMIDE INJECTION [MEITHEAL PHARMACEUTICALS INC.] | 6 | Current NDC, 2 package rows | 20230511_b9abaf64-760d-43e0-8669-a9ca70feab11.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 |
|---|
| 71288-718-10 | 71288071810 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | Historical |
| 71288-718-11 | 71288071811 | 10 VIAL, MULTI-DOSE in 1 CARTON (71288-718-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-718-10) | | 2023-05-08 | No | No | Current |
| 71288-718-91 | 71288071891 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | Historical |
| 71288-718-92 | 71288071892 | 10 VIAL, MULTI-DOSE in 1 CARTON (71288-718-92) / 10 mL in 1 VIAL, MULTI-DOSE (71288-718-91) | | 2023-05-08 | No | No | Current |