NDC 65250-133
EXPAREL
Bupivacaine
EXPAREL is a Infiltration Injection, Suspension, Liposomal in the Human Prescription Drug category. It is labeled and distributed by Pacira Pharmaceuticals Inc.. The primary component is Bupivacaine.
| Product ID | 65250-133_23030401-c18b-4366-b87d-addbe252269b |
| NDC | 65250-133 |
| Product Type | Human Prescription Drug |
| Proprietary Name | EXPAREL |
| Generic Name | Bupivacaine |
| Dosage Form | Injection, Suspension, Liposomal |
| Route of Administration | INFILTRATION |
| Marketing Start Date | 2016-01-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022496 |
| Labeler Name | Pacira Pharmaceuticals Inc. |
| Substance Name | BUPIVACAINE |
| Active Ingredient Strength | 13 mg/mL |
| Pharm Classes | Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 65250-133-04
4 VIAL in 1 CARTON (65250-133-04) > 10 mL in 1 VIAL (65250-133-10)
| Marketing Start Date | 2016-09-02 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 65250-133-10 [65250013310]
EXPAREL INJECTION, SUSPENSION, LIPOSOMAL
| Marketing Category | NDA |
| Application Number | NDA022496 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-01-01 |
NDC 65250-133-04 [65250013304]
EXPAREL INJECTION, SUSPENSION, LIPOSOMAL
| Marketing Category | NDA |
| Application Number | NDA022496 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-09-02 |
NDC 65250-133-09 [65250013309]
EXPAREL INJECTION, SUSPENSION, LIPOSOMAL
| Marketing Category | NDA |
| Application Number | NDA022496 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-09-02 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| BUPIVACAINE | 13.3 mg/mL |
OpenFDA Data
| SPL SET ID: | bb5a9e59-0f51-11df-8a39-0800200c9a66 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Amide Local Anesthetic [EPC]
- Amides [CS]
- Local Anesthesia [PE]
NDC Crossover Matching brand name "EXPAREL" or generic name "Bupivacaine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 65250-133 | EXPAREL | bupivacaine |
| 65250-266 | EXPAREL | bupivacaine |
| 49396-6601 | POSIMIR | Bupivacaine |
| 51715-660 | POSIMIR | bupivacaine |
Trademark Results [EXPAREL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXPAREL 77464815 4074454 Live/Registered |
Pacira Pharmaceuticals, Inc. 2008-05-02 |
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