Rocuronium Bromide
- Product NDC
- 68083-365
- 11-digit product format
- 680830365
- Labeler code
- 68083
- Product ID
- 68083-365_f0786673-741a-4016-9528-268128b3b142
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rocuronium Bromide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA205656
- Marketing category
- ANDA
- Marketing start
- 2018-05-18
- 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 |
|---|
| 68083-365-01 | Rocuronium Bromide | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 9 |
| 68083-365-10 | Rocuronium Bromide | 10 in 1 CARTON | INJECTION | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-365 | ROCURONIUM BROMIDE INJECTION [GLAND PHARMA LIMITED] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250109_a223a740-dbe8-4d06-8b8b-d9104b694e62.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 |
|---|
| 68083-365-01 | 68083036501 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | | Historical |
| 68083-365-10 | 68083036510 | 10 VIAL, MULTI-DOSE in 1 CARTON (68083-365-10) / 10 mL in 1 VIAL, MULTI-DOSE (68083-365-01) | | 2018-05-18 | 0000-00-00 | No | No | Current |