Burapren 0.75%
- Product NDC
- 70529-008
- 11-digit product format
- 705290008
- Labeler code
- 70529
- Product ID
- 70529-008_02e9115c-06fc-4afc-ba57-da8b891e0e76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupivacaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; RETROBULBAR
- Labeler
- IT3 Medical LLC
- Application
- ANDA203895
- Marketing category
- ANDA
- Marketing start
- 2017-03-01
- Marketing end
- 0000-00-00
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 8 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70529-008-01 | Burapren 0.75% | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | | 4 |
| 70529-008-01 | Burapren 0.75% | 1 in 1 PACKAGE | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70529-008 | BURAPREN 0.75% (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [IT3 MEDICAL LLC] | 4 | Legacy NDC, 2 package rows | 20220302_85667365-c166-4fd4-a8dc-d0d3340179fc.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 |
|---|
| 70529-008-01 | 70529000801 | 1 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-008-01) > 30 mL in 1 VIAL, SINGLE-DOSE | 2017-03-01 | 0000-00-00 | No | No | Current |