Prescription drug · NDA
Sensorcaine Mpf NDC 63323-460
bupivacaine hydrochloride and epinephrine bitartrate · Bupivacaine hydrochloride 7.5 mg/mL; Epinephrine bitartrate .005 mg/mL · Injection, Solution · Epidural, Retrobulbar · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-460-37 | 63323046037 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-460-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-460-01)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 — 7.5 mg/mLEpinephrine bitartrate — .005 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Retrobulbar
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018304
- 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 63323-460_2b1a1f80-cb29-4ac1-9e72-20225ed45715SPL ID 2b1a1f80-cb29-4ac1-9e72-20225ed45715SPL set ID eb6d8fee-def4-4c96-9972-695e8cea8ea8RxCUI 1012391, 1012396, 1012404, 1012421, 1012455, 1012457, 1672917, 1672919, 1673296, 1673298, 1724880, 1724881, 1724884, 1724885, 1725078, 1725082, 1725175, 1725177UNII 7TQO7W3VT8, 30Q7KI53AK
- 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
N463323046037followed by a unit qualifier and the quantityPackage 63323-0460-37. 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 infi…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 018304
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 |
|---|---|---|---|---|
| Sensorcainebupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionPerineural | Henry Schein, Inc. | 0404-9947 |
| Sensorcainebupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9945 |
| BUPIVACAINE HCl | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionPerineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1588 |
| BUPIVACAINE HCl | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1592 |
| Sensorcaine Mpfbupivacaine hydrochloride and epinephrine bitartrate | Bupivacaine hydrochloride 5 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-462 |
| 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 |
| Sensorcaine Mpfbupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-464 |
| Sensorcaine Mpfbupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-464 |
| Sensorcaine Mpfbupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-466 |
| Sensorcainebupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-465 |
| Sensorcaine Mpfbupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-466 |
| Sensorcainebupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionPerineural | Fresenius Kabi USA, LLC | 63323-467 |