Prescription drug · ANDA
Sensorcaine MPF (bupivacaine hydrochloride) NDC 0404-9946
Bupivacaine hydrochloride 5 mg/mL · Injection, Solution · Epidural, Intracaudal, Perineural · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9946-10 | 00404994610 | 1 VIAL in 1 BAG (0404-9946-10) / 10 mL in 1 VIALMarketed 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 MPF
- Generic name (nonproprietary)
- bupivacaine hydrochloride
- Active ingredients
- Bupivacaine hydrochloride — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Intracaudal, Perineural
- Labeler
- Henry Schein, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070553
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0404-9946_054a57b2-376c-43ff-af2c-17a073362e29SPL ID 054a57b2-376c-43ff-af2c-17a073362e29SPL set ID 78c6789d-773e-4b26-90bd-34a6b6d730ceRxCUI 1724880, 1724881UNII 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
N400404994610followed by a unit qualifier and the quantityPackage 00404-9946-10. 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)]. Limitations of Use Not all blocks are indicated for use with SENSORCAINE / SENSORCAINE WITH EPINEPHRINE given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), W…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070553
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 |
|---|---|---|---|---|
| Sensorcaine MPFbupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-466 |
| Sensorcaine Mpfbupivacaine hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-466 |