Sevoflurane

Product NDC: 10019-655
11-digit product format: 100190655
Labeler code: 10019
Product ID: 10019-655_51e533f0-ea5a-4210-8fa9-11c1897093a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sevoflurane
Dosage form: LIQUID
Route: RESPIRATORY (INHALATION)
Labeler: Baxter Healthcare Company
Application: ANDA075895
Marketing category: ANDA
Marketing start: 2002-07-02
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	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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075895-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075895-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075895-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075895-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075895-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075895-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075895-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075895-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075895-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075895-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075895-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075895-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075895-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075895-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075895-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075895-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075895-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075895-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075895-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075895-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075895-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075895-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075895-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075895-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075895-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075895-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075895-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075895-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075895-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075895-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075895-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075895-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075895-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075895-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075895-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075895-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075895-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075895-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075895-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075895-001	AN	1	`e64feba35796…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ea8bf997-2c71-4014-b18d-4f7ab45dfa19	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cf7269a1-35c0-eaae-99e6-6fe74a4680f4	Product name	3	20250516

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10019-655-06	Sevoflurane	250 mL in 1 BOTTLE	LIQUID	250		17
10019-655-06	Sevoflurane	6 in 1 CARTON	LIQUID	6		17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
SEVOFLURANE	ACTIVE INGREDIENT	38LVP0K73A	SEVOFLURANE LIQUID [BAXTER HEALTHCARE CORPORATION]	4
SEVOFLURANE	ACTIVE MOIETY	38LVP0K73A	SEVOFLURANE LIQUID [BAXTER HEALTHCARE CORPORATION]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10019-655	SEVOFLURANE LIQUID [BAXTER HEALTHCARE COMPANY]	16	Current NDC, Legacy NDC, 2 package rows	20250424_ea8bf997-2c71-4014-b18d-4f7ab45dfa19.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEVOFLURANE	SEVOFLURANE	Baxter Healthcare Corporation	22700993-851a-48aa-941e-1d2b6b04081f	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075895 application number: ANDA075895
Sevoflurane	SEVOFLURANE	Baxter Healthcare Company	ea8bf997-2c71-4014-b18d-4f7ab45dfa19	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075895 application number: ANDA075895 ndc (product): 10019-655

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
38LVP0K73A	SEVOFLURANE	28523-86-6	SEVOFLURANE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200243	sevoflurane 100 % Inhalation Solution	PSN	ea8bf997-2c71-4014-b18d-4f7ab45dfa19	17
200243	sevoflurane 1000 MG/ML Inhalation Solution	SCD	ea8bf997-2c71-4014-b18d-4f7ab45dfa19	17
200243	sevoflurane 100 % Inhalation Solution	SY	ea8bf997-2c71-4014-b18d-4f7ab45dfa19	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10019-655-06	10019065506	6 BOTTLE in 1 CARTON (10019-655-06) / 250 mL in 1 BOTTLE	6 bottle	2022-07-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sevoflurane, USP Volatile Liquid for Inhalation	Baxter Healthcare Company \| Baxter Healthcare Corporation	2025-03-28	HUMAN PRESCRIPTION DRUG LABEL	17