Bupivacaine Hydrochloride
- Product NDC
- 0404-9826
- 11-digit product format
- 004049826
- Labeler code
- 0404
- Product ID
- 0404-9826_0cb00462-d3e0-48e3-8aab-4569f9318e5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupivacaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INFILTRATION; PERINEURAL
- Labeler
- Henry Schein, Inc
- Application
- ANDA070590
- Marketing category
- ANDA
- Marketing start
- 2021-12-03
- 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
- 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 | 2.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7TQO7W3VT8 |
| Rxcui | 1012396 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9826-50 | Bupivacaine Hydrochloride | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 8 |
| 0404-9826-50 | Bupivacaine Hydrochloride | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9826 | BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240310_3c0f567f-b7f8-4ee8-bfb2-61cd82550498.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9826-50 | 00404982650 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9826-50) / 50 mL in 1 VIAL, MULTI-DOSE | 2021-12-03 | 0000-00-00 | No | No | Current |