Prescription drug · ANDA
0.25% BUPIVACAINE HCl NDC 51662-1606
Bupivacaine hydrochloride 2.5 mg/mL · Injection, Solution · Infiltration, Perineural · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1606-3 | 51662160603 | 25 POUCH in 1 CASE (51662-1606-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1606-2) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Aug 1, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- 0.25% BUPIVACAINE HCl
- Generic name (nonproprietary)
- 0.25% bupivacaine hcl
- Active ingredients
- Bupivacaine hydrochloride — 2.5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Infiltration, Perineural
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070590
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 51662-1606_1b5824c7-c46a-48c6-e063-6394a90a22ceSPL ID 1b5824c7-c46a-48c6-e063-6394a90a22ceSPL set ID 950d82b6-76a1-0c08-e053-2a95a90a3a92RxCUI 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
N451662160603followed by a unit qualifier and the quantityPackage 51662-1606-03. 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)
INDICATIONS & USAGE Bupivacaine Hydrochloride is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (See WARNINGS ). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of Bupivacaine Hydrochloride in these patients. Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia (Bier Block) (See WARNINGS ). The routes of administration and indicated Bupivacaine Hydrochloride co…
Excerpt only. Read the full label for complete information.