Isoflurane, (Volatile for Inhalation)

Product NDC
83301-0071
11-digit product format
833010071
Labeler code
83301
Product ID
83301-0071_785ebf29-1bf1-4efa-8c59-a4a41be9b7f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoflurane
Dosage form
LIQUID
Route
RESPIRATORY (INHALATION)
Labeler
Mullan Pharmaceutical Inc.
Application
ANDA216527
Marketing category
ANDA
Marketing start
2026-04-01
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, (Volatile for Inhalation)
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
83301-0071-1Isoflurane, (Volatile for Inhalation)100 mL in 1 BOTTLE, GLASSLIQUID1001
83301-0071-2Isoflurane, (Volatile for Inhalation)6 in 1 CASELIQUID61

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
542347isoflurane 99.9 % Inhalation SolutionPSN525a2467-548d-4b10-b181-91b90e99ae1b1
542347isoflurane 999 MG/ML Inhalation SolutionSCD525a2467-548d-4b10-b181-91b90e99ae1b1
542347isoflurane 99.9 % Inhalation SolutionSY525a2467-548d-4b10-b181-91b90e99ae1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83301-0071-183301007101100 mL in 1 BOTTLE, GLASS100 mlHistorical
83301-0071-2833010071026 BOTTLE, GLASS in 1 CASE (83301-0071-2) / 100 mL in 1 BOTTLE, GLASS (83301-0071-1) 2026-04-01NoNoCurrent