Prescription drug · ANDA
Bupivacaine Hydrochloride NDC 85766-013
Bupivacaine hydrochloride 5 mg/mL · Injection, Solution · Epidural, Intracaudal, Perineural · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-013-10 | 8576600131085766001310 | 10 mL in 1 VIAL, SINGLE-DOSE (85766-013-10)Marketed from Jun 20, 2025 | |
| 85766-013-25 | 8576600132585766001325 | 25 VIAL, SINGLE-DOSE in 1 TRAY (85766-013-25) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 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 — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Intracaudal, Perineural
- Labeler
- Sportpharm LLCNDC labeler code 85766
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070584
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 85766-013_5d303959-dad2-a680-e063-6394a90abc50SPL ID 5d303959-dad2-a680-e063-6394a90abc50
- 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
N485766001310followed by a unit qualifier and the quantityPackage 85766-0013-10. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 85766-013
- What is NDC 85766-013?
- 85766-013 is the product NDC for Bupivacaine Hydrochloride, Bupivacaine hydrochloride 5 mg/mL injection, solution, listed with the FDA by Sportpharm LLC. It has 2 package NDCs, 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?
- Sportpharm LLC, NDC labeler code 85766. 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 | Fosun Pharma USA Inc. | 72266-263 | 72266-0263-10 |
| 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 |
Other NDCs under ANDA 070584
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 Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Hospira, Inc. | 0409-1162 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Asclemed USA, Inc. | 76420-579 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | ProPharma Distribution | 84549-162 |