Prescription drug · ANDA
Bupivacaine NDC 57884-3251
Bupivacaine 13.3 mg/mL · Injection, Suspension, Liposomal · Infiltration · Jiangsu Hengrui Pharmaceuticals Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57884-3251-1 | 5788432510157884325101 | 10 VIAL in 1 CARTON (57884-3251-1) / 10 mL in 1 VIALMarketed from Jul 1, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Bupivacaine
- Generic name (nonproprietary)
- bupivacaine
- Active ingredients
- Bupivacaine — 13.3 mg/mL
- Dosage form
- Injection, Suspension, Liposomal
- Route
- Infiltration
- Labeler
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.NDC labeler code 57884
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214348
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 57884-3251_1c5d9dbb-0d16-6893-e063-6394a90ad989SPL ID 1c5d9dbb-0d16-6893-e063-6394a90ad989SPL set ID 0af296bb-1599-4b35-b66b-994924d3e898RxCUI 1191508, 1745061UNII Y8335394ROUPC 0357884325119, 0357884325218
- 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
N457884325101followed by a unit qualifier and the quantityPackage 57884-3251-01. 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)
1. INDICATIONS AND USAGE Bupivacaine liposome injectable suspension is indicated to produce postsurgical: Local analgesia via infiltration in adults Regional analgesia via an interscalene brachial plexus nerve block in adults Limitations of Use The safety and effectiveness of bupivacaine liposome injectable suspension have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block. Bupivacaine liposome injectable suspension contains bupivacaine, an amide local anesthetic, and is indicated to produce postsurgical: Local analgesia via infiltration in adults ( 1 ). Regional analgesia via an interscalene brachial ple…
Excerpt only. Read the full label for complete information.
About NDC 57884-3251
- What is NDC 57884-3251?
- 57884-3251 is the product NDC for Bupivacaine, Bupivacaine 13.3 mg/mL injection, suspension, liposomal, listed with the FDA by Jiangsu Hengrui Pharmaceuticals Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bupivacaine.
- What is the active ingredient?
- Bupivacaine.
- Who is the labeler?
- Jiangsu Hengrui Pharmaceuticals Co., Ltd., NDC labeler code 57884. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bupivacaine?
- 1 other product NDC are listed under this name. See all Bupivacaine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bupivacaine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bupivacaine | Bupivacaine 13.3 mg/mL | Injection, Suspension, LiposomalInfiltration | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 57884-3252 | 57884-3252-01 |
Other NDCs under ANDA 214348
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 |
|---|---|---|---|---|
| Bupivacaine | Bupivacaine 13.3 mg/mL | Injection, Suspension, LiposomalInfiltration | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 57884-3252 |