Bupivacaine Hydrochloride
- Product NDC
- 84549-162
- 11-digit product format
- 845490162
- Labeler code
- 84549
- Product ID
- 84549-162_463e0e03-4f19-1b80-e063-6394a90a4da7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INTRACAUDAL; PERINEURAL
- Labeler
- ProPharma Distribution
- Application
- ANDA070584
- Marketing category
- ANDA
- Marketing start
- 2005-11-22
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupivacaine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPIVACAINE HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7TQO7W3VT8 |
| Rxcui | 1724884 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84549-162-02 | Bupivacaine Hydrochloride | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84549-162-02 | 84549016202 | 30 mL in 1 VIAL, SINGLE-DOSE (84549-162-02) | 30 ml | 2025-10-10 | No | No | Historical |