Prescription drug · ANDA
Bupivacaine Hydrochloride NDC 85766-074
Bupivacaine hydrochloride 2.5 mg/mL · Injection, Solution · Epidural, Infiltration, Intracaudal, Perineural · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-074-01 | 85766007401 | 25 VIAL, SINGLE-DOSE in 1 TRAY (85766-074-01) / 10 mL in 1 VIAL, SINGLE-DOSE (85766-074-25)Marketed from Oct 10, 2025 |
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, Intracaudal, Perineural
- Labeler
- Sportpharm LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070583
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 85766-074_5031715d-e871-b54f-e063-6394a90a9d50SPL ID 5031715d-e871-b54f-e063-6394a90a9d50SPL set ID 6f9ebeef-350a-495e-a0bf-c335ab48bf1cRxCUI 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
N485766007401followed by a unit qualifier and the quantityPackage 85766-0074-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. Bupivacaine Hydrochloride Injection contains bupivacaine, an amide local anesthetic, and Bupivacaine Hydrochloride and Epinephrine…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070583
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 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Cardinal Health 107, LLC | 55154-6970 |
| Bupivicaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1456 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Hospira, Inc. | 0409-1159 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Hospira, Inc. | 0409-1159 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | ProPharma Distribution | 84549-259 |