Bupivacaine Hydrochloride with Dextrose
- Product NDC
- 0264-9379
- 11-digit product format
- 002649379
- Labeler code
- 0264
- Product ID
- 0264-9379_d74385e7-1d55-4cf8-90f7-f2e6343eb5f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupivacaine Hydrochloride with Dextrose
- Dosage form
- INJECTION
- Route
- SUBARACHNOID
- Labeler
- B. Braun Medical Inc.
- Application
- ANDA209087
- Marketing category
- ANDA
- Marketing start
- 2019-04-02
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 7.5 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 with Dextrose
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPIVACAINE HYDROCHLORIDE | 7.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7TQO7W3VT8 |
| Rxcui | 1724784 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0264-9379-88 | Bupivacaine Hydrochloride with Dextrose | 2 mL in 1 AMPULE | INJECTION | 2 | | 11 |
| 0264-9379-88 | Bupivacaine Hydrochloride with Dextrose | 10 in 1 CARTON | INJECTION | 10 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0264-9379 | BUPIVACAINE HYDROCHLORIDE WITH DEXTROSE INJECTION [B. BRAUN MEDICAL INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250503_ff43d2b6-acb4-45c8-96b6-971d2a7a6767.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 |
|---|
| 0264-9379-88 | 00264937988 | 10 AMPULE in 1 CARTON (0264-9379-88) / 2 mL in 1 AMPULE | 10 ampule | 2019-04-02 | 0000-00-00 | No | No | Current |