Rocuronium
- Product NDC
- 65219-065
- 11-digit product format
- 652190065
- Labeler code
- 65219
- Product ID
- 65219-065_68f8f5e7-46a8-47f9-a622-6339df1a3d1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROCURONIUM BROMIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA078651
- Marketing category
- ANDA
- Marketing start
- 2022-03-07
- 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
- 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 |
|---|
| 65219-065-02 | Rocuronium | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 1 |
| 65219-065-05 | Rocuronium | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-065 | ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220307_209a654d-f92d-4242-bfef-2dcc90a30d3f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65219-065-02 | 65219006502 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 65219-065-05 | 65219006505 | 10 VIAL in 1 TRAY (65219-065-05) / 5 mL in 1 VIAL (65219-065-02) | 10 vial | 2022-03-07 | 0000-00-00 | No | No | Current |