Prescription drug · ANDA
Sensorcaine Mpf NDC 63323-468
bupivacaine hydrochloride and epinephrine bitartrate · Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .005 mg/mL · Injection, Solution · Epidural, Infiltration, Intracaudal, Perineural · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-468-17 | 63323046817 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-468-17) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-468-01)Marketed from Nov 19, 2010 | |
| 63323-468-37 | 63323046837 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-468-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-468-02)Marketed from Nov 19, 2010 |
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 and epinephrine bitartrate
- Active ingredients
- Bupivacaine hydrochloride — 2.5 mg/mLEpinephrine bitartrate — .005 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration, Intracaudal, Perineural
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070966
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Amides (Chemical structure)Catecholamines (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 63323-468_cc1f6507-eb3e-4398-a1d3-0c56a2099e6bSPL ID cc1f6507-eb3e-4398-a1d3-0c56a2099e6bSPL set ID bc61a9a6-0a4e-48a9-b908-e5e66b9f23ebRxCUI 1012377, 1012384, 1012413, 1012417, 1724786, 1724787, 1724809, 1724810, 1867594, 1867596, 1867618, 1867620UNII 7TQO7W3VT8, 30Q7KI53AKUPC 0363323472030, 0363323461010, 0363323463014, 0363323468026, 0363323472016, 0363323468019
- Pharmacologic class
- Amide Local Anesthetic; Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist
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
N463323046817followed by a unit qualifier and the quantityPackage 63323-0468-17. 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)
SENSORCAINE / SENSORCAINE WITH EPINEPHRINE 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 SENSORCAINE / SENSORCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration ( 2.2 )]. SENSORCAINE contains bupivacaine, an amide local anesthetic, and SENSORCAINE WITH EPINEPHRINE is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. SENSORCAIN…
Excerpt only. Read the full label for complete information.