Home NDC 0527-6123 Sevoflurane
Product NDC 0527-6123
11-digit product format 005276123
Labeler code 0527
Product ID 0527-6123_f3d34dea-e901-46b9-80f8-b314ca57020c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sevoflurane
Dosage form LIQUID
Route RESPIRATORY (INHALATION)
Labeler Lannett Company, Inc.
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A214382-001 SEVOFLURANE SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214382-001 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 2026-08-18 06:07:40 2026-07 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214382-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2023-08-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sevoflurane
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SEVOFLURANE 250 mL/250mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 38LVP0K73A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200243 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-6123-74 Sevoflurane 250 mL in 1 BOTTLE, GLASS LIQUID 250 1 0527-6123-74 Sevoflurane 1 in 1 CARTON LIQUID 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-6123 SEVOFLURANE LIQUID [LANNETT COMPANY, INC.] 1 Current NDC, 2 package rows 20230921_5bfc1cef-824d-4ebf-bb4d-fbc46c0abb79.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0527-6123-74 00527612374 1 BOTTLE, GLASS in 1 CARTON (0527-6123-74) / 250 mL in 1 BOTTLE, GLASS 2023-08-18 No No Current