Rocuronium Bromide
- Product NDC
- 25021-687
- 11-digit product format
- 250210687
- Labeler code
- 25021
- Product ID
- 25021-687_1d066c67-eac2-494a-ad10-ba7e9c60b0e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rocuronium Bromide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA205656
- Marketing category
- ANDA
- Marketing start
- 2023-10-15
- 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 |
|---|
| 25021-687-05 | Rocuronium Bromide | 10 in 1 CARTON | INJECTION | 10 | | 1 |
| 25021-687-05 | Rocuronium Bromide | 5 mL in 1 VIAL | INJECTION | 5 | | 1 |
| 25021-687-10 | Rocuronium Bromide | 10 in 1 CARTON | INJECTION | 10 | | 1 |
| 25021-687-10 | Rocuronium Bromide | 10 mL in 1 VIAL | INJECTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-687 | ROCURONIUM BROMIDE INJECTION [SAGENT PHARMACEUTICALS] | 1 | Current NDC, 4 package rows | 20231018_01825411-be08-4402-b101-cb546291c972.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 |
|---|
| 25021-687-05 | 25021068705 | 10 VIAL in 1 CARTON (25021-687-05) / 5 mL in 1 VIAL | 10 vial | 2023-10-15 | No | No | Historical |
| 25021-687-10 | 25021068710 | 10 VIAL in 1 CARTON (25021-687-10) / 10 mL in 1 VIAL | 10 vial | 2023-10-15 | No | No | Historical |