Bupivacaine Hydrochloride
- Product NDC
- 76420-008
- 11-digit product format
- 764200008
- Labeler code
- 76420
- Product ID
- 76420-008_ead08199-44c1-c795-e053-2995a90a7e08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupivacaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INTRACAUDAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA203895
- Marketing category
- ANDA
- Marketing start
- 2013-11-05
- 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 | 1724880 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-008-10 | Bupivacaine Hydrochloride | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-008 | BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [ASCLEMED USA, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20221013_a60303c2-5217-41db-855b-83fa2a749da2.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 |
|---|
| 76420-008-10 | 76420000810 | 10 mL in 1 VIAL, SINGLE-DOSE (76420-008-10) | 10 ml | 2020-01-16 | 0000-00-00 | No | No | Current |