Home NDC 10019-653 SEVOFLURANE
Product NDC 10019-653
11-digit product format 100190653
Labeler code 10019
Product ID 10019-653_e04090f9-97a3-4fe5-9bc1-c4a86ac9a6a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sevoflurane
Dosage form LIQUID
Route RESPIRATORY (INHALATION)
Labeler Baxter Healthcare Corporation
Application ANDA075895
Marketing category ANDA
Marketing start 2002-07-07
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 A075895-001 SEVOFLURANE SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075895-001 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.
Product history page 1 of 2 · 42 observed 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 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075895-001 SEVOFLURANE 100% LIQUID / INHALATION AN 2002-07-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075895-001 AN 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075895-001 AN 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base SEVOFLURANE
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 10019-653-64 SEVOFLURANE 250 mL in 1 BOTTLE LIQUID 250 14 10019-653-64 SEVOFLURANE 6 in 1 CARTON LIQUID 6 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10019-653 SEVOFLURANE LIQUID [BAXTER HEALTHCARE CORPORATION] 13 Current NDC, Legacy NDC, 2 package rows 20250501_22700993-851a-48aa-941e-1d2b6b04081f.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10019-653-64 10019065364 6 BOTTLE in 1 CARTON (10019-653-64) / 250 mL in 1 BOTTLE 6 bottle 2002-07-07 0000-00-00 No No Current