Prescription drug · ANDA
bupivacaine hydrochloride NDC 72603-279
Bupivacaine hydrochloride 2.5 mg/mL · Injection, Solution · Infiltration, Perineural · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-279-25 | 72603027925 | 25 VIAL, MULTI-DOSE in 1 CARTON (72603-279-25) / 50 mL in 1 VIAL, MULTI-DOSE (72603-279-01)Marketed from Dec 16, 2024 |
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
- Infiltration, Perineural
- Labeler
- Northstar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216039
- Marketing start
- Marketing end
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 72603-279_4439cf55-3d69-4363-984f-dee716b14472SPL ID 4439cf55-3d69-4363-984f-dee716b14472SPL set ID adadc041-8d5e-4bf8-a89b-e227729a880dRxCUI 1012396, 1012404UNII 7TQO7W3VT8UPC 0372603279252, 0372603287011, 0372603287257, 0372603279016
- 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
N472603027925followed by a unit qualifier and the quantityPackage 72603-0279-25. 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 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) ]. 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 (2.2) , Contraindications (4) , Warnings and Precautions (5…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216039
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 5 mg/mL | Injection, SolutionPerineural | Northstar Rx LLC | 72603-287 |
| bupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionPerineural | Meitheal Pharmaceuticals Inc | 71288-726 |
| bupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | Meitheal Pharmaceuticals Inc | 71288-723 |