FDA.reportPublic FDA data

Ultane

Product NDC
0074-4456
11-digit product format
000744456
Labeler code
0074
Product ID
0074-4456_20a177a4-8440-46f9-98f4-c51d395e4a46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevoflurane
Dosage form
LIQUID
Route
RESPIRATORY (INHALATION)
Labeler
AbbVie Inc.
Application
NDA020478
Marketing category
NDA
Marketing start
1995-06-07
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
Ultane
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEVOFLURANE250 mL/250mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii38LVP0K73A
Rxcui200243, 541963

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-4456-04Ultane250 mL in 1 BOTTLE, PLASTICLIQUID2501479
0074-4456-51Ultane250 mL in 1 BOTTLE, PLASTICLIQUID2501458

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-4456-04ML - Milliliter0074-4456bd1f873d-8e37-41e0-a137-56dbcde301f412012-07-24
0074-4456-51ML - Milliliter0074-44563fbf16f5-a45f-4c7b-a67d-0ef7947742cc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SEVOFLURANEACTIVE INGREDIENT38LVP0K73AULTANE (SEVOFLURANE) LIQUID [ABBVIE INC.]1433
SEVOFLURANEACTIVE MOIETY38LVP0K73AULTANE (SEVOFLURANE) LIQUID [ABBVIE INC.]1433
SEVOFLURANEACTIVE INGREDIENT38LVP0K73AULTANE (SEVOFLURANE) LIQUID [ABBVIE INC.]1430
SEVOFLURANEACTIVE MOIETY38LVP0K73AULTANE (SEVOFLURANE) LIQUID [ABBVIE INC.]1430

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-4456ULTANE (SEVOFLURANE) LIQUID [ABBVIE INC.]1479Current NDC, Legacy NDC, 1 package rows20250214_4c6e76bc-c964-4955-e0a3-511d3386a9cc.zip
0074-4456ULTANE (SEVOFLURANE) LIQUID [ABBVIE INC.]1458Current NDC, Legacy NDC, 1 package rows20250224_c9aa6489-5a36-44ed-9512-b996833d82f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200243sevoflurane 100 % Inhalation SolutionPSN4c6e76bc-c964-4955-e0a3-511d3386a9cc1479
541963ULTANE 100 % Inhalation SolutionPSN4c6e76bc-c964-4955-e0a3-511d3386a9cc1479
541963sevoflurane 1000 MG/ML Inhalation Solution [Ultane]SBD4c6e76bc-c964-4955-e0a3-511d3386a9cc1479
200243sevoflurane 1000 MG/ML Inhalation SolutionSCD4c6e76bc-c964-4955-e0a3-511d3386a9cc1479
200243sevoflurane 100 % Inhalation SolutionSY4c6e76bc-c964-4955-e0a3-511d3386a9cc1479
541963Ultane 100 % Inhalation SolutionSY4c6e76bc-c964-4955-e0a3-511d3386a9cc1479
541963Ultane 1000 MG/ML Inhalation SolutionSY4c6e76bc-c964-4955-e0a3-511d3386a9cc1479
200243sevoflurane 100 % Inhalation SolutionPSNc9aa6489-5a36-44ed-9512-b996833d82f71458
541963ULTANE 100 % Inhalation SolutionPSNc9aa6489-5a36-44ed-9512-b996833d82f71458
541963sevoflurane 1000 MG/ML Inhalation Solution [Ultane]SBDc9aa6489-5a36-44ed-9512-b996833d82f71458
200243sevoflurane 1000 MG/ML Inhalation SolutionSCDc9aa6489-5a36-44ed-9512-b996833d82f71458
200243sevoflurane 100 % Inhalation SolutionSYc9aa6489-5a36-44ed-9512-b996833d82f71458
541963Ultane 100 % Inhalation SolutionSYc9aa6489-5a36-44ed-9512-b996833d82f71458
541963Ultane 1000 MG/ML Inhalation SolutionSYc9aa6489-5a36-44ed-9512-b996833d82f71458

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-4456-0400074445604250 mL in 1 BOTTLE, PLASTIC (0074-4456-04) 250 ml1995-06-070000-00-00NoNoCurrent
0074-4456-5100074445651250 mL in 1 BOTTLE, PLASTIC (0074-4456-51) 250 ml1995-06-070000-00-00NoNoCurrent