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

Additional Listing Data#

Finished product
Yes
Brand name base
Isoflurane
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOFLURANE100 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCYS9AKD70P
Rxcui542347

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac9629df-d32a-4233-ad61-63593097af8aProduct name120220516

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42677-326-01Isoflurane1 in 1 CARTONLIQUID14
42677-326-01Isoflurane100 mL in 1 BOTTLE, GLASSLIQUID1004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
542347isoflurane 99.9 % Inhalation SolutionPSN662ceaf6-650b-4dea-bbee-652f464260244
542347isoflurane 999 MG/ML Inhalation SolutionSCD662ceaf6-650b-4dea-bbee-652f464260244
542347isoflurane 99.9 % Inhalation SolutionSY662ceaf6-650b-4dea-bbee-652f464260244

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42677-326-01426770326011 BOTTLE, GLASS in 1 CARTON (42677-326-01) / 100 mL in 1 BOTTLE, GLASS2025-11-04NoNoHistorical