isoflurane

Generic: isoflurane

Labeler: shandong new time pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isoflurane
Generic Name isoflurane
Labeler shandong new time pharmaceutical co., ltd.
Dosage Form LIQUID
Routes
RESPIRATORY (INHALATION)
Active Ingredients

isoflurane 100 mL/100mL

Manufacturer
Shandong New Time Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 42677-326
Product ID 42677-326_47b13264-ce08-a7fd-e063-6394a90ad6eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216527
Listing Expiration 2027-12-31
Marketing Start 2025-11-04

Pharmacologic Class

Established (EPC)
general anesthetic [epc]
Physiologic Effect
general anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42677326
Hyphenated Format 42677-326

Supplemental Identifiers

RxCUI
542347
UNII
CYS9AKD70P
NUI
N0000175975 N0000175681

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 isoflurane (source: ndc)
Generic Name isoflurane (source: ndc)
Application Number ANDA216527 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 100 mL/100mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (42677-326-01) / 100 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

42677-326-01 1 BOTTLE, GLASS in 1 CARTON (42677-326-01) / 100 mL in 1 BOTTLE, GLASS

Ingredients (1)

isoflurane (100 mL/100mL)

Linked Drug Pages (1)

Isoflurane ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "47b13264-ce08-a7fd-e063-6394a90ad6eb", "openfda": {"nui": ["N0000175975", "N0000175681"], "unii": ["CYS9AKD70P"], "rxcui": ["542347"], "spl_set_id": ["662ceaf6-650b-4dea-bbee-652f46426024"], "pharm_class_pe": ["General Anesthesia [PE]"], "pharm_class_epc": ["General Anesthetic [EPC]"], "manufacturer_name": ["Shandong New Time Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (42677-326-01)  / 100 mL in 1 BOTTLE, GLASS", "package_ndc": "42677-326-01", "marketing_start_date": "20251104"}], "brand_name": "Isoflurane", "product_id": "42677-326_47b13264-ce08-a7fd-e063-6394a90ad6eb", "dosage_form": "LIQUID", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "42677-326", "generic_name": "Isoflurane", "labeler_name": "Shandong New Time Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isoflurane", "active_ingredients": [{"name": "ISOFLURANE", "strength": "100 mL/100mL"}], "application_number": "ANDA216527", "marketing_category": "ANDA", "marketing_start_date": "20251104", "listing_expiration_date": "20271231"}