bupivacaine spinal

Generic: bupivacaine hydrochloride in dextrose

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine spinal
Generic Name bupivacaine hydrochloride in dextrose
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBARACHNOID
Active Ingredients

bupivacaine hydrochloride 7.5 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-3613
Product ID 0409-3613_43a8f8dd-af5e-486d-bd36-a7f2956f2bc0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071810
Listing Expiration 2026-12-31
Marketing Start 2005-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04093613
Hyphenated Format 0409-3613

Supplemental Identifiers

RxCUI
1724784
UNII
7TQO7W3VT8

Packaging Origin

Original Packager
true

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 bupivacaine spinal (source: ndc)
Generic Name bupivacaine hydrochloride in dextrose (source: ndc)
Application Number ANDA071810 (source: ndc)
Routes
SUBARACHNOID
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/mL
source: ndc
Packaging
  • 10 AMPULE in 1 CARTON (0409-3613-01) / 2 mL in 1 AMPULE (0409-3613-11)
source: ndc

Packages (1)

0409-3613-01 10 AMPULE in 1 CARTON (0409-3613-01) / 2 mL in 1 AMPULE (0409-3613-11)

Ingredients (1)

bupivacaine hydrochloride (7.5 mg/mL)

Linked Drug Pages (1)

Bupivacaine Spinal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBARACHNOID"], "spl_id": "43a8f8dd-af5e-486d-bd36-a7f2956f2bc0", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1724784"], "spl_set_id": ["7a8d2539-4422-4312-0298-207ef1a2948e"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 CARTON (0409-3613-01)  / 2 mL in 1 AMPULE (0409-3613-11)", "package_ndc": "0409-3613-01", "marketing_start_date": "20050131"}], "brand_name": "Bupivacaine Spinal", "product_id": "0409-3613_43a8f8dd-af5e-486d-bd36-a7f2956f2bc0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "0409-3613", "generic_name": "BUPIVACAINE HYDROCHLORIDE IN DEXTROSE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine", "brand_name_suffix": "Spinal", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "7.5 mg/mL"}], "application_number": "ANDA071810", "marketing_category": "ANDA", "marketing_start_date": "20050131", "listing_expiration_date": "20261231"}