bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

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

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride
Generic Name bupivacaine hydrochloride
Labeler camber pharmaceuticals, inc.
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL RETROBULBAR
Active Ingredients

bupivacaine hydrochloride 7.5 mg/mL

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-277
Product ID 31722-277_2b597d4a-6ad3-7bc9-e063-6294a90aede0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217821
Listing Expiration 2026-12-31
Marketing Start 2024-03-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722277
Hyphenated Format 31722-277

Supplemental Identifiers

RxCUI
1724786 1724787 1724880 1724884 1725078 1725082
UPC
0331722276306 0331722276108 0331722275101 0331722277303 0331722277105 0331722275309
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 hydrochloride (source: ndc)
Generic Name bupivacaine hydrochloride (source: ndc)
Application Number ANDA217821 (source: ndc)
Routes
EPIDURAL RETROBULBAR
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-31) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-277-10)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-32) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-277-10)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-33) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-277-30)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-34) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-277-30)
source: ndc

Packages (4)

31722-277-31 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-31) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-277-10) 31722-277-32 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-32) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-277-10) 31722-277-33 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-33) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-277-30) 31722-277-34 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-34) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-277-30)

Ingredients (1)

bupivacaine hydrochloride (7.5 mg/mL)

Linked Drug Pages (1)

BUPIVACAINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "RETROBULBAR"], "spl_id": "2b597d4a-6ad3-7bc9-e063-6294a90aede0", "openfda": {"upc": ["0331722276306", "0331722276108", "0331722275101", "0331722277303", "0331722277105", "0331722275309"], "unii": ["7TQO7W3VT8"], "rxcui": ["1724786", "1724787", "1724880", "1724884", "1725078", "1725082"], "spl_set_id": ["0e552e3a-cf52-4d74-9381-6cc1b29b4c90"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-31)  / 10 mL in 1 VIAL, SINGLE-DOSE (31722-277-10)", "package_ndc": "31722-277-31", "marketing_start_date": "20240327"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-32)  / 10 mL in 1 VIAL, SINGLE-DOSE (31722-277-10)", "package_ndc": "31722-277-32", "marketing_start_date": "20240327"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-33)  / 30 mL in 1 VIAL, SINGLE-DOSE (31722-277-30)", "package_ndc": "31722-277-33", "marketing_start_date": "20240327"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-34)  / 30 mL in 1 VIAL, SINGLE-DOSE (31722-277-30)", "package_ndc": "31722-277-34", "marketing_start_date": "20240327"}], "brand_name": "BUPIVACAINE HYDROCHLORIDE", "product_id": "31722-277_2b597d4a-6ad3-7bc9-e063-6294a90aede0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "31722-277", "generic_name": "BUPIVACAINE HYDROCHLORIDE", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPIVACAINE HYDROCHLORIDE", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "7.5 mg/mL"}], "application_number": "ANDA217821", "marketing_category": "ANDA", "marketing_start_date": "20240327", "listing_expiration_date": "20261231"}