Bupivacaine Hydrochloride
- Product NDC
- 50090-4516
- 11-digit product format
- 500904516
- Labeler code
- 50090
- Product ID
- 50090-4516_c7485abb-d059-4e91-8cd2-215cb93828ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupivacaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- PERINEURAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA207183
- Marketing category
- ANDA
- Marketing start
- 2016-05-13
- 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 | 1012404 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-4516-0 | 2023-02-07 | C162847 | 48780-1 | f386c64a-1e13-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use BUPIVACAINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BUPIVACAINE HYDROCHLORIDE INJECTION. BUPIVACAINE HYDROCHLORIDE injection, for infiltration, perineural, caudal, epidural, or retrobulbar use Initial U.S. Approval: 1972 |
| 50090-4516-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1e13-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use BUPIVACAINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BUPIVACAINE HYDROCHLORIDE INJECTION. BUPIVACAINE HYDROCHLORIDE injection, for infiltration, perineural, caudal, epidural, or retrobulbar use Initial U.S. Approval: 1972 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-4516-0 | 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 |
|---|
| 50090-4516 | BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 8 | Current NDC, Legacy NDC, 1 package rows | 20240601_1091d4d8-5dad-46e1-8f26-7bc0c5dd833f.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 |
|---|
| 50090-4516-0 | 50090451600 | 50 mL in 1 VIAL, MULTI-DOSE (50090-4516-0) | 50 ml | 2019-09-11 | 0000-00-00 | No | No | Current |