Sevoflurane Bostonbio

Product NDC
72163-005
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72163-005IInactivated by FDA2026-08-17
excluded packagepackage72163-00572163-005-25IInactivated by FDA2026-08-17

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72163-005-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72163-005-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72163-005-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72163-005-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72163-005-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72163-005-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72163-005-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72163-005-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72163-005-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72163-005-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72163-005-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72163-005-25557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage72163-005-258af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage72163-005-25834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage72163-005-251332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage72163-005-25fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage72163-005-2586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage72163-005-25bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage72163-005-258dfbde2a14a4…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078650-001SEVOFLURANESEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078650-001AN

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-193f01610625f2…
2019-09-15 20:21 UTC2019-09A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078650-001SEVOFLURANE100%LIQUID / INHALATIONAN2007-11-19e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078650-001AN1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078650-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078650-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078650-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078650-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078650-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078650-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078650-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078650-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078650-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078650-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078650-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078650-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078650-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078650-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078650-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078650-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078650-001AN14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078650-001AN174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078650-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078650-001AN1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078650-001AN187673890dc5c…
2021-03-12 10:30 UTC2021-03A078650-001AN15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078650-001AN18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078650-001AN1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078650-001AN13f01610625f2…
2019-09-15 20:21 UTC2019-09A078650-001AN1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078650-001AN1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078650-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078650-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078650-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078650-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078650-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078650-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078650-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078650-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078650-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078650-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078650-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078650-001AN1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf7269a1-35c0-eaae-99e6-6fe74a4680f4Product name320250516

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72163-005-252021-07-23C16284748780-1c7ccaba7-1827-fd44-e053-dadaa90aa01b9b63721d-3c58-0e03-e053-2a95a90ab02a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72163-005-25Sevoflurane Bostonbio250 mL in 1 BOTTLE, GLASSINHALANT2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72163-005SEVOFLURANE BOSTONBIO (SEVOFLURANE) INHALANT [BOSTON BIOPHARMA]3Legacy NDC, 1 package rows20200911_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SevofluraneSEVOFLURANEHalocarbon Life Sciences, LLCbdde7502-6218-401c-9a4f-dd3bc3a80f722025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078650
application number: ANDA078650

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200243sevoflurane 100 % Inhalation SolutionPSN9b63721d-3c58-0e03-e053-2a95a90ab02a3
200243sevoflurane 1000 MG/ML Inhalation SolutionSCD9b63721d-3c58-0e03-e053-2a95a90ab02a3
200243sevoflurane 100 % Inhalation SolutionSY9b63721d-3c58-0e03-e053-2a95a90ab02a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72163-005-2572163000525250 mL in 1 BOTTLE, GLASS (72163-005-25) 250 ml2020-03-270000-00-00NoNoCurrent