Prescription drug · ANDA
Bupivacaine HCl (bupivacaine hydrochloride) NDC 70594-119
Bupivacaine hydrochloride 5 mg/mL · Injection, Solution · Perineural · Xellia Pharmaceuticals USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70594-119-01 | 70594011901 | 50 mL in 1 VIAL, MULTI-DOSE (70594-119-01)Marketed from Aug 1, 2023 |
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 HCl
- Generic name (nonproprietary)
- bupivacaine hydrochloride
- Active ingredients
- Bupivacaine hydrochloride — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Perineural
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091503
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 70594-119_6776a37a-5872-4c0c-b039-6d93e3604e7cSPL ID 6776a37a-5872-4c0c-b039-6d93e3604e7cSPL set ID 3335dabe-66d5-440b-a59a-b62993030e0fRxCUI 1012396, 1012404UNII 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
N470594011901followed by a unit qualifier and the quantityPackage 70594-0119-01. 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)
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) ]. Bupivacaine hydrochloride injection contains bupivacaine, an amide local anesthetic. Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery proce…
Excerpt only. Read the full label for complete information.