Home NDC 83301-0070 Sevoflurane, (Volatile for Inhalation)
Product NDC 83301-0070
11-digit product format 833010070
Labeler code 83301
Product ID 83301-0070_4db52cc7-3ca6-0aaf-e063-6294a90a0dc1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sevoflurane
Dosage form LIQUID
Route RESPIRATORY (INHALATION)
Labeler Mullan Pharmaceutical Inc.
Application ANDA214382
Marketing category ANDA
Marketing start 2026-02-16
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 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, (Volatile for Inhalation)
Listing expiration 2027-12-31 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 83301-0070-1 Sevoflurane, (Volatile for Inhalation) 1 in 1 CARTON LIQUID 1 3 83301-0070-1 Sevoflurane, (Volatile for Inhalation) 250 mL in 1 BOTTLE, GLASS LIQUID 250 3
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 83301-0070-1 83301007001 1 BOTTLE, GLASS in 1 CARTON (83301-0070-1) / 250 mL in 1 BOTTLE, GLASS 2026-02-16 No No Current