Prescription drug · ANDA
Bupivacaine Hydrochloride NDC 31722-275
Bupivacaine hydrochloride 2.5 mg/mL · Injection, Solution · Epidural, Infiltration, Intracaudal, Perineural · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-275-31 | 31722027531 | 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-275-31) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-275-10)Marketed from Mar 27, 2024 | |
| 31722-275-32 | 31722027532 | 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-275-32) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-275-10)Marketed from Mar 27, 2024 | |
| 31722-275-33 | 31722027533 | 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-275-33) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-275-30)Marketed from Mar 27, 2024 | |
| 31722-275-34 | 31722027534 | 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-275-34) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-275-30)Marketed from Mar 27, 2024 | |
| 31722-275-35 | 31722027535 | 50 VIAL, SINGLE-DOSE in 1 CARTON (31722-275-35) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-275-30)Marketed from Mar 27, 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
- Epidural, Infiltration, Intracaudal, Perineural
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217821
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 31722-275_4ea16f8e-77de-3ba7-e063-6394a90a5667SPL ID 4ea16f8e-77de-3ba7-e063-6394a90a5667SPL set ID 0e552e3a-cf52-4d74-9381-6cc1b29b4c90RxCUI 1724786, 1724787, 1724880, 1724884, 1725078, 1725082UNII 7TQO7W3VT8UPC 0331722276306, 0331722276108, 0331722275101, 0331722277303, 0331722277105, 0331722275309
- 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
N431722027531followed by a unit qualifier and the quantityPackage 31722-0275-31. 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, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection is 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 Precaut…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217821
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 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | NorthStar RxLLC | 72603-327 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | NorthStar RxLLC | 72603-415 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | NorthStar RxLLC | 72603-506 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | Camber Pharmaceuticals, Inc. | 31722-277 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Camber Pharmaceuticals, Inc. | 31722-276 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | NorthStar RxLLC | 72603-602 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | NorthStar RxLLC | 72603-700 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | NorthStar RxLLC | 72603-800 |
- openFDA data updated
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