Prescription drug · NDA
Exparel (Bupivacaine) NDC 65250-266
Bupivacaine 13.3 mg/mL · Injection, Suspension, Liposomal · Infiltration · Pacira Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65250-266-04 | 65250026604 | 4 VIAL in 1 CARTON (65250-266-04) / 20 mL in 1 VIAL (65250-266-20)Marketed from Sep 28, 2016 | |
| 65250-266-09 | 65250026609 | 10 VIAL in 1 CARTON (65250-266-09) / 20 mL in 1 VIAL (65250-266-20)Marketed from Mar 31, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Exparel
- Generic name (nonproprietary)
- bupivacaine
- Active ingredients
- Bupivacaine — 13.3 mg/mL
- Dosage form
- Injection, Suspension, Liposomal
- Route
- Infiltration
- Labeler
- Pacira Pharmaceuticals, Inc.NDC labeler code 65250
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022496
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 65250-266_7dd52279-ea2e-4f8c-8e29-8172bc3ed882SPL ID 7dd52279-ea2e-4f8c-8e29-8172bc3ed882SPL set ID bb5a9e59-0f51-11df-8a39-0800200c9a66RxCUI 1191508, 1191513, 1745061, 1745062UNII Y8335394RO
- Pharmacologic class
- Amide Local Anesthetic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N465250026604followed by a unit qualifier and the quantityPackage 65250-0266-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
EXPAREL is indicated to produce postsurgical: Local analgesia via infiltration in patients aged 6 years and older Regional analgesia via an interscalene brachial plexus nerve block in adults Regional analgesia via a sciatic nerve block in the popliteal fossa in adults Regional analgesia via an adductor canal block in adults EXPAREL contains bupivacaine, an amide local anesthetic, and is indicated to produce postsurgical: Local analgesia via infiltration in patients aged 6 years and older ( 1 ). Regional analgesia via an interscalene brachial plexus nerve block in adults ( 1 ). Regional analgesia via a sciatic nerve block in the popliteal fossa in adults ( 1 ). Regional analgesia via an adduc…
Excerpt only. Read the full label for complete information.
About NDC 65250-266
- What is NDC 65250-266?
- 65250-266 is the product NDC for Exparel (bupivacaine), Bupivacaine 13.3 mg/mL injection, suspension, liposomal, listed with the FDA by Pacira Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Exparel (Bupivacaine).
- What is the active ingredient?
- Bupivacaine.
- Who is the labeler?
- Pacira Pharmaceuticals, Inc., NDC labeler code 65250. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Exparel?
- 1 other product NDC are listed under this name. See all Exparel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Exparel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Exparelbupivacaine | Bupivacaine 13.3 mg/mL | Injection, Suspension, LiposomalInfiltration | Pacira Pharmaceuticals, Inc. | 65250-133 | 65250-0133-0465250-0133-09 |
Other NDCs under NDA 022496
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Exparelbupivacaine | Bupivacaine 13.3 mg/mL | Injection, Suspension, LiposomalInfiltration | Pacira Pharmaceuticals, Inc. | 65250-133 |