Prescription drug · ANDA
Bupivacaine Hydrochloride NDC 72266-263
Bupivacaine hydrochloride 2.5 mg/mL · Injection, Solution · Epidural, Infiltration · Fosun Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72266-263-10 | 7226602631072266026310 | 10 VIAL in 1 CARTON (72266-263-10) / 10 mL in 1 VIALMarketed from Feb 6, 2026 |
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)
- Bupivacaine Hydrochloride
- Generic name (nonproprietary)
- bupivacaine hydrochloride
- Active ingredients
- Bupivacaine hydrochloride — 2.5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration
- Labeler
- Fosun Pharma USA Inc.NDC labeler code 72266
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091487
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 72266-263_55904ca6-a5ad-76ce-e063-6294a90ac5e0SPL ID 55904ca6-a5ad-76ce-e063-6294a90ac5e0SPL set ID 3a996abe-0bb9-4590-e063-6394a90a0b60RxCUI 1724880, 1725078UNII 7TQO7W3VT8
- 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
N472266026310followed by a unit qualifier and the quantityPackage 72266-0263-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [ see Dosage and Administration (2.2) ]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [ see Dosage and Administration (2.2) , Contraindications (4) , Warnings and Precautions …
Excerpt only. Read the full label for complete information.
About NDC 72266-263
- What is NDC 72266-263?
- 72266-263 is the product NDC for Bupivacaine Hydrochloride, Bupivacaine hydrochloride 2.5 mg/mL injection, solution, listed with the FDA by Fosun Pharma USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bupivacaine Hydrochloride.
- What is the active ingredient?
- Bupivacaine hydrochloride.
- Who is the labeler?
- Fosun Pharma USA Inc., NDC labeler code 72266. 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 Hydrochloride?
- 70 other product NDCs are listed under this name. See all Bupivacaine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bupivacaine Hydrochloride 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 Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Anthea Pharma Private Limited | 83854-004 | 83854-0004-1083854-0004-11 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | Anthea Pharma Private Limited | 83854-005 | 83854-0005-1083854-0005-11 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionPerineural | Anthea Pharma Private Limited | 83854-006 | 83854-0006-01 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Anthea Pharma Private Limited | 83854-039 | 83854-0039-1083854-0039-11 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | Anthea Pharma Private Limited | 83854-038 | 83854-0038-01 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural | Fosun Pharma USA Inc. | 72266-264 | 72266-0264-10 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-162 | 83270-0162-10 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-165 | 83270-0165-01 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-163 | 83270-0163-10 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-164 | 83270-0164-10 |
Other NDCs under ANDA 091487
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 HClbupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Xellia Pharmaceuticals USA LLC | 70594-117 |
| Bupivacaine HClbupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Xellia Pharmaceuticals USA LLC | 70594-118 |
| Bupivacaine HClbupivacaine hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Xellia Pharmaceuticals USA LLC | 70594-120 |
| Bupivacine HClbupivacaine hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Xellia Pharmaceuticals USA LLC | 70594-121 |
| Bupivacaine HClbupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Xellia Pharmaceuticals USA LLC | 70594-114 |
| BUPIVACAINE HClbupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Xellia Pharmaceuticals USA LLC | 70594-115 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-162 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-163 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-164 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-165 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-166 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-167 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural | Fosun Pharma USA Inc. | 72266-264 |