Home NDC 42677-326 Isoflurane
Product NDC 42677-326
11-digit product format 426770326
Labeler code 42677
Product ID 42677-326_47b13264-ce08-a7fd-e063-6394a90ad6eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isoflurane
Dosage form LIQUID
Route RESPIRATORY (INHALATION)
Labeler Shandong New Time Pharmaceutical Co., Ltd.
Application ANDA216527
Marketing category ANDA
Marketing start 2025-11-04
Substance ISOFLURANE
Active strength 100 mL/100mL
Pharmacologic classes General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216527-001 ISOFLURANE ISOFLURANE 99.9% LIQUID / INHALATION AN 2025-11-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216527-001 AN
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216527-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 2025-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216527-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 2025-11-04 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216527-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 2025-11-04 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216527-001 AN 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216527-001 AN 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216527-001 AN 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Isoflurane
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOFLURANE 100 mL/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CYS9AKD70P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 542347 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42677-326-01 Isoflurane 1 in 1 CARTON LIQUID 1 4 42677-326-01 Isoflurane 100 mL in 1 BOTTLE, GLASS LIQUID 100 4
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42677-326-01 42677032601 1 BOTTLE, GLASS in 1 CARTON (42677-326-01) / 100 mL in 1 BOTTLE, GLASS 2025-11-04 No No Current