Home NDC 0074-4456 Ultane
Product NDC 0074-4456
11-digit product format 000744456
Labeler code 0074
Product ID 0074-4456_20a177a4-8440-46f9-98f4-c51d395e4a46
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sevoflurane
Dosage form LIQUID
Route RESPIRATORY (INHALATION)
Labeler AbbVie Inc.
Application NDA020478
Marketing category NDA
Marketing start 1995-06-07
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 N020478-001 ULTANE SEVOFLURANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020478-001 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 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020478-001 ULTANE 100% LIQUID / INHALATION AN RLD, RS 1995-06-07 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ultane
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200243 Internal RxNorm lookup 541963 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 0074-4456-04 Ultane 250 mL in 1 BOTTLE, PLASTIC LIQUID 250 1479 0074-4456-51 Ultane 250 mL in 1 BOTTLE, PLASTIC LIQUID 250 1458
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0074-4456 ULTANE (SEVOFLURANE) LIQUID [ABBVIE INC.] 1479 Current NDC, Legacy NDC, 1 package rows 20250214_4c6e76bc-c964-4955-e0a3-511d3386a9cc.zip 0074-4456 ULTANE (SEVOFLURANE) LIQUID [ABBVIE INC.] 1458 Current NDC, Legacy NDC, 1 package rows 20250224_c9aa6489-5a36-44ed-9512-b996833d82f7.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 0074-4456-04 00074445604 250 mL in 1 BOTTLE, PLASTIC (0074-4456-04) 250 ml 1995-06-07 0000-00-00 No No Current 0074-4456-51 00074445651 250 mL in 1 BOTTLE, PLASTIC (0074-4456-51) 250 ml 1995-06-07 0000-00-00 No No Current