Sevoflurane Bostonbio

Product NDC: 72163-005
Requested package NDC: 72163-005-25
11-digit product format: 721630005
Labeler code: 72163
Product ID: 72163-005_aeede82b-056f-e016-e053-2995a90ab36a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sevoflurane
Dosage form: INHALANT
Route: RESPIRATORY (INHALATION)
Labeler: Boston Biopharma
Application: ANDA078650
Marketing category: ANDA
Marketing start: 2020-03-27
Marketing end: 0000-00-00
Substance: SEVOFLURANE
Active strength: 1 mL/mL
Pharmacologic classes: General Anesthesia [PE],General Anesthetic [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72163-005	72163-005-25	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 19 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`

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
A078650-001	SEVOFLURANE	SEVOFLURANE	100%	LIQUID / INHALATION	AN		2007-11-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078650-001	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	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`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	A078650-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078650-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078650-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078650-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078650-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078650-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078650-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078650-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078650-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078650-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078650-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078650-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078650-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078650-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078650-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078650-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078650-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078650-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078650-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078650-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078650-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078650-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078650-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078650-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078650-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078650-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078650-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078650-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078650-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078650-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078650-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078650-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078650-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078650-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078650-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078650-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078650-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078650-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078650-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078650-001	AN	1	`e64feba35796…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72163-005-25	2021-07-23	C162847	48780-1	c7ccaba7-1827-fd44-e053-dadaa90aa01b	9b63721d-3c58-0e03-e053-2a95a90ab02a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72163-005-25	Sevoflurane Bostonbio	250 mL in 1 BOTTLE, GLASS	INHALANT	250		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72163-005	SEVOFLURANE BOSTONBIO (SEVOFLURANE) INHALANT [BOSTON BIOPHARMA]	3	Legacy NDC, 1 package rows	20200911_9b63721d-3c58-0e03-e053-2a95a90ab02a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sevoflurane	SEVOFLURANE	Halocarbon Life Sciences, LLC	bdde7502-6218-401c-9a4f-dd3bc3a80f72	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078650 application number: ANDA078650

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	9b63721d-3c58-0e03-e053-2a95a90ab02a	3
200243	sevoflurane 1000 MG/ML Inhalation Solution	SCD	9b63721d-3c58-0e03-e053-2a95a90ab02a	3
200243	sevoflurane 100 % Inhalation Solution	SY	9b63721d-3c58-0e03-e053-2a95a90ab02a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72163-005-25	72163000525	250 mL in 1 BOTTLE, GLASS (72163-005-25)	250 ml	2020-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sevoflurane Bostonbio - Boston Biopharma \| Halocarbon Life Sciences, LLC \| Pharmasol Corporation	Boston Biopharma \| Halocarbon Life Sciences, LLC \| Pharmasol Corporation	2020-09-09	HUMAN PRESCRIPTION DRUG LABEL	3