EXPAREL
- Product NDC
- 65250-133
- 11-digit product format
- 652500133
- Labeler code
- 65250
- Product ID
- 65250-133_7dd52279-ea2e-4f8c-8e29-8172bc3ed882
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupivacaine
- Dosage form
- INJECTION, SUSPENSION, LIPOSOMAL
- Route
- INFILTRATION
- Labeler
- Pacira Pharmaceuticals, Inc.
- Application
- NDA022496
- Marketing category
- NDA
- Marketing start
- 2016-01-01
- Substance
- BUPIVACAINE
- Active strength
- 13.3 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
- EXPAREL
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPIVACAINE | 13.3 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Y8335394RO |
| Rxcui | 1191508, 1191513, 1745061, 1745062 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cbf85893-59ef-423f-87d4-a573c000a8b9 | Product name | 8 | 20250731 |
| 5dad6767-dcd1-b0da-8727-7f3f7bc3a435 | Product name | 2 | 20250303 |
| e3a99641-4540-4894-9108-00cab3c57b7e | Product name | 1 | 20211207 |
| 5da98533-f072-406b-9e1b-6ac19eca9926 | Product name | 1 | 20210622 |
| 306b993e-3140-4823-ad5e-88b708f9d2ac | Product name | 1 | 20210510 |
| a831e694-3663-4a83-82be-6c309429f750 | Product name | 2 | 20200608 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65250-133-04 | EXPAREL | 4 in 1 CARTON | INJECTION, SUSPENSION, LIPOSOMAL | 4 | 32 | |
| 65250-133-09 | EXPAREL | 10 in 1 CARTON | INJECTION, SUSPENSION, LIPOSOMAL | 10 | 32 | |
| 65250-133-10 | EXPAREL | 10 mL in 1 VIAL | INJECTION, SUSPENSION, LIPOSOMAL | 10 | 32 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65250-133-04 | ML - Milliliter | 65250-133 | 59eadd1e-1c8e-4e4c-ab11-4b802c104a24 | 1 | 2017-03-06 |
| 65250-133-09 | ML - Milliliter | 65250-133 | 205fe808-ba20-4b7f-a0da-d7615d7b4a20 | 1 | 2017-03-06 |
| 65250-133-10 | ML - Milliliter | 65250-133 | 46b1495f-d9ae-4308-a443-1ece37f29375 | 1 | 2017-03-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BUPIVACAINE | ACTIVE INGREDIENT | Y8335394RO | EXPAREL (BUPIVACAINE) INJECTION, SUSPENSION, LIPOSOMAL [PACIRA PHARMACEUTICALS INC.] | 6 | |
| BUPIVACAINE | ACTIVE MOIETY | Y8335394RO | EXPAREL (BUPIVACAINE) INJECTION, SUSPENSION, LIPOSOMAL [PACIRA PHARMACEUTICALS INC.] | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1745061 | BUPivacaine liposome 1.3 % in 10 ML Injection | PSN | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1191508 | BUPivacaine liposome 1.3 % in 20 ML Injection | PSN | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1745062 | EXPAREL 1.3 % in 10 ML Injection | PSN | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1191513 | EXPAREL 1.3 % in 20 ML Injection | PSN | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1745062 | 10 ML bupivacaine liposome 13.3 MG/ML Injection [Exparel] | SBD | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1191513 | 20 ML bupivacaine liposome 13.3 MG/ML Injection [Exparel] | SBD | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1745061 | 10 ML bupivacaine liposome 13.3 MG/ML Injection | SCD | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1191508 | 20 ML bupivacaine liposome 13.3 MG/ML Injection | SCD | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1745062 | 10 ML Exparel 13.3 MG/ML Injection | SY | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1191513 | 20 ML Exparel 13.3 MG/ML Injection | SY | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1191508 | bupivacaine liposome 1.3 % in 20 ML Injection | SY | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1745061 | bupivacaine liposome 133 MG per 10 ML Injection | SY | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1191508 | bupivacaine liposome 266 MG per 20 ML Injection | SY | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1191513 | Exparel 1.3 % in 20 ML Injection | SY | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1745062 | Exparel 133 MG per 10 ML Injection | SY | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
| 1191513 | Exparel 266 MG per 20 ML Injection | SY | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 32 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65250-133-04 | 65250013304 | 4 VIAL in 1 CARTON (65250-133-04) / 10 mL in 1 VIAL (65250-133-10) | 4 vial | 2016-09-02 | 0000-00-00 | No | No | Current |
| 65250-133-09 | 65250013309 | 10 VIAL in 1 CARTON (65250-133-09) / 10 mL in 1 VIAL (65250-133-10) | 10 vial | 2016-09-02 | 0000-00-00 | No | No | Current |
| 65250-133-10 | 65250013310 | 10 mL in 1 VIAL | 10 ml | Historical |