Sevoflurane

Product NDC
42677-308
11-digit product format
426770308
Labeler code
42677
Product ID
42677-308_47b367ce-bae5-a5cf-e063-6294a90acd21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevoflurane
Dosage form
LIQUID
Route
RESPIRATORY (INHALATION)
Labeler
Shandong New Time Pharmaceutical Co., Ltd.
Application
ANDA214382
Marketing category
ANDA
Marketing start
2023-08-18
Substance
SEVOFLURANE
Active strength
250 mL/250mL
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
Sevoflurane
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42677-308-01Sevoflurane250 mL in 1 BOTTLE, GLASSLIQUID2505
42677-308-01Sevoflurane1 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42677-308SEVOFLURANE LIQUID [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.]4Current NDC, 2 package rows20241127_c808afe1-ebf1-44cf-9187-09656331bff5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42677-308-01426770308011 BOTTLE, GLASS in 1 CARTON (42677-308-01) / 250 mL in 1 BOTTLE, GLASS2023-08-18NoNoCurrent