Bupivacaine Hydrochloride NDC 85766-013

NDC codes

FDA NDC Directory

Product NDC (as listed)85766-013Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85766-0013Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
85766-013-10	85766001310	10 mL in 1 VIAL, SINGLE-DOSE (85766-013-10)Marketed from Jun 20, 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 — 5 mg/mL
Dosage form: Injection, Solution
Route: Epidural, Intracaudal, Perineural
Labeler: Sportpharm LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 070584
Marketing start: Nov 22, 2005
Listing expires: Dec 31, 2027
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 85766-013_49eeda32-7627-4c62-e063-6394a90af3ebSPL ID 49eeda32-7627-4c62-e063-6394a90af3ebSPL set ID 0e6a55f0-5107-4ea9-9ee1-5c6c09bbe4a6RxCUI 1724880UNII 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

N485766001310 followed by a unit qualifier and the quantity

Package 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

Current FDA label (SPL), effective Feb 3, 2026. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 070584

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 070584
Product	Strength	Form · route	Labeler	Product NDC
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Intracaudal, Perineural	ProPharma Distribution	84549-162
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