marcaine

Generic: bupivacine hydrochloride

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name marcaine
Generic Name bupivacine hydrochloride
Labeler henry schein, inc.
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INTRACAUDAL PERINEURAL
Active Ingredients

bupivacaine hydrochloride 5 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9768
Product ID 0404-9768_fc5fd272-2b75-47c6-a1cd-7201ca102030
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016964
Listing Expiration 2027-12-31
Marketing Start 2026-01-26

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049768
Hyphenated Format 0404-9768

Supplemental Identifiers

RxCUI
1724884 1725046
UNII
7TQO7W3VT8

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name marcaine (source: ndc)
Generic Name bupivacine hydrochloride (source: ndc)
Application Number NDA016964 (source: ndc)
Routes
EPIDURAL INTRACAUDAL PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9768-30) / 30 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9768-30 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9768-30) / 30 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

bupivacaine hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Marcaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INTRACAUDAL", "PERINEURAL"], "spl_id": "fc5fd272-2b75-47c6-a1cd-7201ca102030", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1724884", "1725046"], "spl_set_id": ["7d94e8e0-0d1e-4af3-973a-a480d7d51737"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9768-30)  / 30 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9768-30", "marketing_start_date": "20260126"}], "brand_name": "Marcaine", "product_id": "0404-9768_fc5fd272-2b75-47c6-a1cd-7201ca102030", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "0404-9768", "generic_name": "bupivacine hydrochloride", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Marcaine", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "NDA016964", "marketing_category": "NDA", "marketing_start_date": "20260126", "listing_expiration_date": "20271231"}