rocuronium bromide
- Product NDC
- 39822-4200
- 11-digit product format
- 398224200
- Labeler code
- 39822
- Product ID
- 39822-4200_eedcfb07-4e23-3152-e053-2995a90a6e6a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rocuronium bromide
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- XGen Pharmaceuticals DJB, Inc.
- Application
- ANDA091115
- Marketing category
- ANDA
- Marketing start
- 2012-12-01
- 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 |
|---|
| 39822-4200-1 | rocuronium bromide | 5 mL in 1 VIAL | SOLUTION | 5 | | 20 |
| 39822-4200-2 | rocuronium bromide | 10 in 1 CARTON | SOLUTION | 10 | | 20 |
| 39822-4200-5 | rocuronium bromide | 10 mL in 1 VIAL | SOLUTION | 10 | | 20 |
| 39822-4200-6 | rocuronium bromide | 10 in 1 CARTON | SOLUTION | 10 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ROCURONIUM BROMIDE | ACTIVE INGREDIENT | I65MW4OFHZ | ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| ROCURONIUM | ACTIVE MOIETY | WRE554RFEZ | ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| NITROGEN | INACTIVE INGREDIENT | N762921K75 | ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ROCURONIUM BROMIDE SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 39822-4200 | ROCURONIUM BROMIDE SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] | 20 | Current NDC, Legacy NDC, 4 package rows | 20221217_b73f192c-2912-4ec3-9b4f-05a58d9b35ba.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 |
|---|
| 39822-4200-1 | 39822420001 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 39822-4200-2 | 39822420002 | 10 VIAL in 1 CARTON (39822-4200-2) / 5 mL in 1 VIAL (39822-4200-1) | 10 vial | 2012-12-01 | 0000-00-00 | No | No | Current |
| 39822-4200-5 | 39822420005 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 39822-4200-6 | 39822420006 | 10 VIAL in 1 CARTON (39822-4200-6) / 10 mL in 1 VIAL (39822-4200-5) | 10 vial | 2012-12-01 | 0000-00-00 | No | No | Current |