Prescription drug · ANDA
BUPIVACAINE HYDROCHLORIDE injection, solution NDC 51662-1638
Bupivacaine hydrochloride 5 mg/mL · Injection, Solution · Perineural · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1638-3 | 5166216380351662163803 | 25 POUCH in 1 CASE (51662-1638-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1638-2) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Oct 2, 2023 |
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)
- BUPIVACAINE HYDROCHLORIDE injection, solution
- Generic name (nonproprietary)
- bupivacaine hydrochloride injection, solution
- Active ingredients
- Bupivacaine hydrochloride — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Perineural
- Labeler
- HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207183
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 51662-1638_0f952dd8-92a8-2eb0-e063-6394a90a8c35SPL ID 0f952dd8-92a8-2eb0-e063-6394a90a8c35SPL set ID 06c15208-c600-7173-e063-6394a90a2f94RxCUI 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
N451662163803followed by a unit qualifier and the quantityPackage 51662-1638-03. 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)
Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, 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 ]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS ].…
Excerpt only. Read the full label for complete information.
About NDC 51662-1638
- What is NDC 51662-1638?
- 51662-1638 is the product NDC for BUPIVACAINE HYDROCHLORIDE injection, solution, Bupivacaine hydrochloride 5 mg/mL injection, solution, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- BUPIVACAINE HYDROCHLORIDE injection, solution.
- What is the active ingredient?
- Bupivacaine hydrochloride.
- Who is the labeler?
- HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. 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 injection, solution?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 207183
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 Hci | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1581 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionPerineural | A-S Medication Solutions | 50090-4516 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | Eugia US LLC | 55150-249 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionPerineural | Eugia US LLC | 55150-250 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | Medical Purchasing Solutions, LLC | 71872-7133 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionPerineural | Medical Purchasing Solutions, LLC | 71872-7270 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | Sportpharm LLC | 85766-305 |