Prescription drug · ANDA
Sensorcaine(R) (Bupivacaine Hci And Epinephrine) NDC 51662-1397
Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .005 mg/mL · Injection, Solution · Infiltration, Perineural · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1397-1 | 51662139701 | 50 mL in 1 VIAL, MULTI-DOSE (51662-1397-1)Marketed from Oct 8, 2019 | |
| 51662-1397-2 | 51662139702 | 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1397-2) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 26, 2021 | |
| 51662-1397-3 | 51662139703 | 25 POUCH in 1 CASE (51662-1397-3) / 1 VIAL, MULTI-DOSE in 1 POUCH / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 26, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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(R) (Bupivacaine Hci And Epinephrine)
- Generic name (nonproprietary)
- sensorcaine(r) (bupivacaine hci and epinephrine)
- Active ingredients
- Bupivacaine hydrochloride — 2.5 mg/mLEpinephrine bitartrate — .005 mg/mL
- Dosage form
- Injection, Solution
- Route
- Infiltration, Perineural
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070967
- 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 51662-1397_1032a94b-35f3-8839-e063-6394a90a5f7bSPL ID 1032a94b-35f3-8839-e063-6394a90a5f7bSPL set ID 946ce625-3647-5083-e053-2a95a90a1ebcRxCUI 1012377UNII 7TQO7W3VT8, 30Q7KI53AKUPC 0363323461577
- 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
N451662139701followed by a unit qualifier and the quantityPackage 51662-1397-01. 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 & 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: (See DOSAGE …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070967
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 and epinephrine bitartrate | Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-461 |