Vivacaine NDC 0362-9011

NDC codes

FDA NDC Directory

Product NDC (as listed)0362-9011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00362-9011Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0362-9011-50	00362901150	50 CARTRIDGE in 1 CARTON (0362-9011-50) / 1.8 mL in 1 CARTRIDGEMarketed from Jun 1, 2013

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): Vivacaine
Generic name (nonproprietary): bupivacaine hydrochloride and epinephrine bitartrate
Active ingredients: Bupivacaine hydrochloride anhydrous — 5 mg/mLEpinephrine bitartrate — .005 mg/mL
Dosage form: Injection, Solution
Route: Submucosal
Labeler: Septodont, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077250
Marketing start: Jun 1, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Amides (Chemical structure)Catecholamines (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 0362-9011_a427016b-7421-413c-85fc-64f583ebe336SPL ID a427016b-7421-413c-85fc-64f583ebe336SPL set ID b4c60d8e-e350-45b2-9d6b-5815eeb6c994RxCUI 1012461, 1670365UNII AKA908P8J1, 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

N400362901150 followed by a unit qualifier and the quantity

Package 00362-9011-50. 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 Feb 16, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) is indicated for the production of local anesthesia for dental procedures by infiltration injection or nerve block in adults. Vivacaine® is not recommended for children.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077250

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077250
Product	Strength	Form · route	Labeler	Product NDC
Marcainebupivacaine hydrochloride and epinephrine bitartrate	Bupivacaine hydrochloride anhydrous 5 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	Septodont, Inc.	0362-0557