Home NDC 66794-021 Desflurane
Product NDC 66794-021
11-digit product format 667940021
Labeler code 66794
Product ID 66794-021_561c51aa-76fe-2eb8-e063-6394a90a7021
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desflurane
Dosage form LIQUID
Route RESPIRATORY (INHALATION)
Labeler Piramal Critical Care Inc
Application ANDA090363
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-07-01
Substance DESFLURANE
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 66794-021-25 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66794-021-25 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66794-021-25 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090363-001 DESFLURANE DESFLURANE 100% LIQUID / INHALATION AN 2026-10-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090363-001 AN
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A090363-001 DESFLURANE 100% LIQUID / INHALATION AN 2026-10-05 c2088c7a36db…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A090363-001 AN 1 c2088c7a36db…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Desflurane
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESFLURANE 250 mL/250mL
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2023-02-06 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DESFLURANE USP, LIQUID FOR INHALATION safely and effectively. See full prescribing information for DESFLURANE USP, LIQUID FOR INHALATION. DESFLURANE USP, liquid for inhalation use Initial U.S. Approval: 1992 2023-02-06 These highlights do not include all the information needed to use DESFLURANE USP, LIQUID FOR INHALATION safely and effectively. See full prescribing information for DESFLURANE USP, LIQUID FOR INHALATION. DESFLURANE USP, liquid for inhalation use Initial U.S. Approval: 1992 2020-01-31 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DESFLURANE USP, LIQUID FOR INHALATION safely and effectively. See full prescribing information for DESFLURANE USP, LIQUID FOR INHALATION. DESFLURANE USP, liquid for inhalation use Initial U.S. Approval: 1992 2020-01-31 These highlights do not include all the information needed to use DESFLURANE USP, LIQUID FOR INHALATION safely and effectively. See full prescribing information for DESFLURANE USP, LIQUID FOR INHALATION. DESFLURANE USP, liquid for inhalation use Initial U.S. Approval: 1992
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66794-021-25 Desflurane 250 mL in 1 BOTTLE, GLASS LIQUID 250 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66794-021 DESFLURANE LIQUID [PIRAMAL CRITICAL CARE INC] 7 Current NDC, Legacy NDC, 1 package rows 20240515_80883017-6797-43b2-a500-36843e7e1aff.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 66794-021-25 66794002125 250 mL in 1 BOTTLE, GLASS 250 ml Historical 66794-021-35 66794002135 6 BOTTLE in 1 CARTON (66794-021-35) / 250 mL in 1 BOTTLE (66794-021-20) 6 bottle 2026-07-01 No No Current 66794-021-40 66794002140 6 BOTTLE, GLASS in 1 CARTON (66794-021-40) / 250 mL in 1 BOTTLE, GLASS (66794-021-25) 2026-10-25 No No Current