Bupivacaine Hydrochloride
- Product NDC
- 83270-168
- 11-digit product format
- 832700168
- Labeler code
- 83270
- Product ID
- 83270-168_4ab54553-749b-6bc7-e063-6394a90ad9fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupivacaine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INFILTRATION
- Labeler
- ONESOURCE SPECIALTY PHARMA LIMITED
- Application
- ANDA091503
- Marketing category
- ANDA
- Marketing start
- 2026-01-29
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 2.5 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupivacaine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPIVACAINE HYDROCHLORIDE | 2.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7TQO7W3VT8 |
| Rxcui | 1012396, 1012404 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83270-168-01 | Bupivacaine Hydrochloride | 50 mL in 1 VIAL | INJECTION, SOLUTION | 50 | | 1 |
| 83270-168-01 | Bupivacaine Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83270-168-01 | 83270016801 | 1 VIAL in 1 CARTON (83270-168-01) / 50 mL in 1 VIAL | 1 vial | 2026-01-29 | No | No | Current |