FDA.reportPublic FDA data

Desflurane

Product NDC
0781-6172
11-digit product format
007816172
Labeler code
0781
Product ID
0781-6172_ecf9968e-58b0-4792-e053-2995a90aef25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desflurane
Dosage form
LIQUID
Route
RESPIRATORY (INHALATION)
Labeler
Sandoz Inc.
Application
ANDA208234
Marketing category
ANDA
Marketing start
2018-02-26
Substance
DESFLURANE
Active strength
240 mL/240mL
Pharmacologic classes
General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desflurane
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESFLURANE240 mL/240mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCRS35BZ94Q
Rxcui562366

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fe60a7eb-08e5-4869-98ba-7cc2b17e8491Product name120180529

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-6172-862021-08-03C16284748780-1c7ccaba7-161d-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use DESFLURANE, LIQUID FOR INHALATION safely and effectively. See full prescribing information for DESFLURANE, LIQUID FOR INHALATION. DESFLURANE, liquid for inhalation use Initial U.S. Approval: 1992
0781-6172-862021-07-23C16284748780-1c7ccaba7-161d-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use DESFLURANE, LIQUID FOR INHALATION safely and effectively. See full prescribing information for DESFLURANE, LIQUID FOR INHALATION. DESFLURANE, liquid for inhalation use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-6172-22Desflurane240 mL in 1 BOTTLE, GLASSLIQUID24010
0781-6172-86Desflurane6 in 1 CARTONLIQUID610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-6172-22ML - Milliliter0781-6172f88d9cf6-81f9-43bc-a5d5-a66db31b00f312019-02-13
0781-6172-86ML - Milliliter0781-6172322366eb-f3aa-4435-b721-c436eea00b6912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-6172DESFLURANE LIQUID [SANDOZ INC.]10Current NDC, Legacy NDC, 2 package rows20221202_21ba0e18-3dbc-4feb-a3a4-f6470c00910a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562366desflurane 100 % Inhalation SolutionPSN21ba0e18-3dbc-4feb-a3a4-f6470c00910a10
562366desflurane 1000 MG/ML Inhalation SolutionSCD21ba0e18-3dbc-4feb-a3a4-f6470c00910a10
562366desflurane 100 % Inhalation SolutionSY21ba0e18-3dbc-4feb-a3a4-f6470c00910a10
562366desflurane 99 % Inhalation SolutionSY21ba0e18-3dbc-4feb-a3a4-f6470c00910a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-6172-2200781617222240 mL in 1 BOTTLE, GLASS240 mlHistorical
0781-6172-86007816172866 BOTTLE, GLASS in 1 CARTON (0781-6172-86) / 240 mL in 1 BOTTLE, GLASS (0781-6172-22) 2018-02-260000-00-00NoNoCurrent