Prescription drug · ANDA
Sensorcaine Mpf (Bupivacaine hydrochloride) NDC 63323-464
Bupivacaine hydrochloride 2.5 mg/mL · Injection, Solution · Epidural, Infiltration, Intracaudal, Perineural · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-464-38 | 6332304643863323046438 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-464-38) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-464-08)Marketed from Jul 29, 2022 |
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)
- Sensorcaine MpfSuffix: MPF
- Generic name (nonproprietary)
- bupivacaine hydrochloride
- Active ingredients
- Bupivacaine hydrochloride — 2.5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration, Intracaudal, Perineural
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070552
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 63323-464_d3ba9fb9-63c8-4597-bb0a-cd01d31a24b6SPL ID d3ba9fb9-63c8-4597-bb0a-cd01d31a24b6SPL set ID b6bfc04a-1868-4630-9ca1-8c027af97ce3RxCUI 1724880, 1724881, 1724884, 1724885, 1725078, 1725082, 1725175, 1725177UNII 7TQO7W3VT8UPC 0363323464080, 0363323466084
- 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
N463323046438followed by a unit qualifier and the quantityPackage 63323-0464-38. 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 AND USAGE: Sensorcaine (bupivacaine HCl) 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 the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS ). The routes of administration and indicated Sensorcaine concentrations are: local inf…
Excerpt only. Read the full label for complete information.
About NDC 63323-464
- What is NDC 63323-464?
- 63323-464 is the product NDC for Sensorcaine Mpf (bupivacaine hydrochloride), Bupivacaine hydrochloride 2.5 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sensorcaine Mpf (Bupivacaine hydrochloride).
- What is the active ingredient?
- Bupivacaine hydrochloride.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sensorcaine Mpf?
- 6 other product NDCs are listed under this name. See all Sensorcaine Mpf NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sensorcaine Mpf products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sensorcaine MPFbupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Henry Schein, Inc. | 0404-9946 | 00404-9946-10 |
| Sensorcaine Mpfbupivacaine hydrochloride and epinephrine bitartrate | Bupivacaine hydrochloride 7.5 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionEpidural, Retrobulbar | Fresenius Kabi USA, LLC | 63323-460 | 63323-0460-37 |
| Sensorcaine Mpfbupivacaine hydrochloride and epinephrine bitartrate | Bupivacaine hydrochloride 5 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-462 | 63323-0462-1763323-0462-3163323-0462-37 |
| Sensorcaine Mpfbupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-466 | 63323-0466-39 |
| Sensorcaine Mpfbupivacaine hydrochloride and epinephrine bitartrate | Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-468 | 63323-0468-38 |
| Sensorcaine Mpfbupivacaine hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | Fresenius Kabi USA, LLC | 63323-472 | 63323-0472-1763323-0472-37 |