Prescription drug · NDA
Sensorcaine (Bupivacaine hydrochloride) NDC 0404-9947
Bupivacaine hydrochloride 5 mg/mL · Injection, Solution · Perineural · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9947-50 | 0040499475000404994750 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9947-50) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 12, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Generic name (nonproprietary)
- bupivacaine hydrochloride
- Active ingredients
- Bupivacaine hydrochloride — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Perineural
- Labeler
- Henry Schein, Inc.NDC labeler code 0404
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018304
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0404-9947_6f90cc96-c462-455f-a92b-47ac6722d062SPL ID 6f90cc96-c462-455f-a92b-47ac6722d062SPL set ID 100201ad-6e4d-4e91-8b5c-621d0bf0dcc2RxCUI 1012404, 1012457UNII 7TQO7W3VT8
- 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
N400404994750followed by a unit qualifier and the quantityPackage 00404-9947-50. 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 .
Indications (excerpt from the label)
INDICATIONS & 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: Standard textb…
Excerpt only. Read the full label for complete information.
About NDC 0404-9947
- What is NDC 0404-9947?
- 0404-9947 is the product NDC for Sensorcaine (bupivacaine hydrochloride), Bupivacaine hydrochloride 5 mg/mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sensorcaine (Bupivacaine Hydrochloride).
- What is the active ingredient?
- Bupivacaine hydrochloride.
- Who is the labeler?
- Henry Schein, Inc., NDC labeler code 0404. 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?
- 6 other product NDCs are listed under this name. See all Sensorcaine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sensorcaine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sensorcainebupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9945 | 00404-9945-50 |
| Sensorcainebupivacaine hydrochloride and epinephrine bitartrate | Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-461 | 63323-0461-57 |
| Sensorcainebupivacaine hydrochloride and epinephrine bitartrate | Bupivacaine hydrochloride 5 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionPerineural | Fresenius Kabi USA, LLC | 63323-463 | 63323-0463-57 |
| Sensorcainebupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-465 | 63323-0465-57 |
| Sensorcainebupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionPerineural | Fresenius Kabi USA, LLC | 63323-467 | 63323-0467-57 |
| Sensorcainebupivacaine hydrochloride and epinephrine bitartrate | Bupivacaine hydrochloride 5 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionPerineural | Sportpharm LLC | 85766-255 | 85766-0255-25 |
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 |
|---|---|---|---|---|
| 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 |
| Sensorcainebupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9945 |
| Sensorcainebupivacaine hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-465 |
| Sensorcainebupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionPerineural | Fresenius Kabi USA, LLC | 63323-467 |
| 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 |
| 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 5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-466 |