Sevoflurane

Product NDC: 42677-308
Requested package NDC: 42677-308-01
11-digit product format: 426770308
Labeler code: 42677
Product ID: 42677-308_535139ad-7d0e-fbf6-e063-6394a90ab048
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sevoflurane
Dosage form: LIQUID
Route: RESPIRATORY (INHALATION)
Labeler: Shandong New Time Pharmaceutical Co., Ltd.
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214382-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2023-08-18	`84e616aacf4f…`
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214382-001	AN	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214382-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214382-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214382-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214382-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214382-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214382-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214382-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214382-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214382-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214382-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214382-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214382-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214382-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214382-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214382-001	AN	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214382-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214382-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214382-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214382-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214382-001	AN	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214382-001	AN	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
c808afe1-ebf1-44cf-9187-09656331bff5	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
42677-308-01	Sevoflurane	250 mL in 1 BOTTLE, GLASS	LIQUID	250		5
42677-308-01	Sevoflurane	1 in 1 CARTON	LIQUID	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42677-308	SEVOFLURANE LIQUID [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.]	4	Current NDC, 2 package rows	20241127_c808afe1-ebf1-44cf-9187-09656331bff5.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sevoflurane	SEVOFLURANE	Shandong New Time Pharmaceutical Co., Ltd.	c808afe1-ebf1-44cf-9187-09656331bff5	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214382 application number: ANDA214382 ndc (package): 42677-308-01 ndc (product): 42677-308 ndc11 (package): 42677030801
Sevoflurane, (Volatile for Inhalation)	SEVOFLURANE	Mullan Pharmaceutical Inc.	0ca6da3a-6a18-400d-8c49-08a5534b025f	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214382 application number: ANDA214382
Sevoflurane	SEVOFLURANE	Lannett Company, Inc.	5bfc1cef-824d-4ebf-bb4d-fbc46c0abb79	2023-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214382 application number: ANDA214382

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
42677-308-01	42677030801	1 BOTTLE, GLASS in 1 CARTON (42677-308-01) / 250 mL in 1 BOTTLE, GLASS	2023-08-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sevoflurane USP volatile liquid for inhalation	Shandong New Time Pharmaceutical Co., Ltd.	2026-06-02	HUMAN PRESCRIPTION DRUG LABEL	6