FDA.reportPublic FDA data

Sevoflurane

Product NDC
0781-6160
11-digit product format
007816160
Labeler code
0781
Product ID
0781-6160_ecf89ead-16b2-91cf-e053-2995a90adc93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevoflurane
Dosage form
LIQUID
Route
RESPIRATORY (INHALATION)
Labeler
Sandoz Inc.
Application
ANDA203793
Marketing category
ANDA
Marketing start
2017-01-25
Substance
SEVOFLURANE
Active strength
250 mL/250mL
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
Sevoflurane
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEVOFLURANE250 mL/250mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii38LVP0K73A
Rxcui200243

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf7269a1-35c0-eaae-99e6-6fe74a4680f4Product name320250516

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-6160-862021-08-03C16284748780-1c7ccaba7-247e-fd44-e053-dadaa90aa01bSevoflurane USP volatile liquid for inhalation
0781-6160-862021-07-23C16284748780-1c7ccaba7-247e-fd44-e053-dadaa90aa01bSevoflurane USP volatile liquid for inhalation

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-6160-43Sevoflurane250 mL in 1 BOTTLE, GLASSLIQUID25015
0781-6160-86Sevoflurane6 in 1 CARTONLIQUID615

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-6160-43ML - Milliliter0781-6160628c3280-c778-4eef-9529-eabb6481f0d912017-03-06
0781-6160-86ML - Milliliter0781-6160ef095f7f-fe67-46a0-97df-459da6c558a312017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SEVOFLURANEACTIVE INGREDIENT38LVP0K73ASEVOFLURANE LIQUID [SANDOZ INC.]1
SEVOFLURANEACTIVE MOIETY38LVP0K73ASEVOFLURANE LIQUID [SANDOZ INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-6160SEVOFLURANE LIQUID [SANDOZ INC.]15Current NDC, Legacy NDC, 2 package rows20221202_8604f245-fa99-4092-9042-058aa42e0b74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200243sevoflurane 100 % Inhalation SolutionPSN8604f245-fa99-4092-9042-058aa42e0b7415
200243sevoflurane 1000 MG/ML Inhalation SolutionSCD8604f245-fa99-4092-9042-058aa42e0b7415
200243sevoflurane 100 % Inhalation SolutionSY8604f245-fa99-4092-9042-058aa42e0b7415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-6160-4300781616043250 mL in 1 BOTTLE, GLASS250 mlHistorical
0781-6160-86007816160866 BOTTLE, GLASS in 1 CARTON (0781-6160-86) / 250 mL in 1 BOTTLE, GLASS (0781-6160-43) 2017-01-250000-00-00NoNoCurrent