Sojourn

Product NDC
66794-012
11-digit product format
667940012
Labeler code
66794
Product ID
66794-012_44ded994-d330-0d67-e063-6394a90a92db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevoflurane
Dosage form
LIQUID
Route
RESPIRATORY (INHALATION)
Labeler
Piramal Critical Care Inc
Application
ANDA077867
Marketing category
ANDA
Marketing start
2010-04-13
Substance
SEVOFLURANE
Active strength
1 mL/mL
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077867-001SOJOURNSEVOFLURANE100%LIQUID / INHALATIONAN2007-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077867-001AN

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 06:07:402026-07A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-023f01610625f2…
2019-09-15 20:21 UTC2019-09A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077867-001SOJOURN100%LIQUID / INHALATIONAN2007-05-02e64feba35796…

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 06:07:402026-07A077867-001AN1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077867-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077867-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077867-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077867-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077867-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077867-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077867-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077867-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077867-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077867-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077867-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077867-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077867-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077867-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077867-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077867-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077867-001AN14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077867-001AN174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077867-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077867-001AN1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077867-001AN187673890dc5c…
2021-03-12 10:30 UTC2021-03A077867-001AN15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077867-001AN18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077867-001AN1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077867-001AN13f01610625f2…
2019-09-15 20:21 UTC2019-09A077867-001AN1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077867-001AN1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077867-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077867-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077867-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077867-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077867-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077867-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077867-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077867-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077867-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077867-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077867-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077867-001AN1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Sojourn
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEVOFLURANE1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
38LVP0K73AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200243Internal RxNorm lookup
997625Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fedfd1db-7e32-44b2-89e9-7bb00ee6810dAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66794-012-25Sojourn250 mL in 1 BOTTLE, GLASSLIQUID25029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66794-012-25ML - Milliliter66794-01254244e62-8878-472b-8952-9c501206b60612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SEVOFLURANEACTIVE INGREDIENT38LVP0K73ASOJOURN (SEVOFLURANE) LIQUID [PIRAMAL CRITICAL CARE INC]11
SEVOFLURANEACTIVE MOIETY38LVP0K73ASOJOURN (SEVOFLURANE) LIQUID [PIRAMAL CRITICAL CARE INC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-012SOJOURN (SEVOFLURANE) LIQUID [PIRAMAL CRITICAL CARE INC]26Current NDC, Legacy NDC, 1 package rows20250403_fedfd1db-7e32-44b2-89e9-7bb00ee6810d.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SojournSEVOFLURANEPiramal Critical Care Incfedfd1db-7e32-44b2-89e9-7bb00ee6810d2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077867
application number: ANDA077867
ndc (product): 66794-012
SevofluraneSEVOFLURANEPiramal Critical Care Incb23e14d7-9e5b-13f4-e053-2a95a90a0cde2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077867
application number: ANDA077867
SevofluraneSEVOFLURANEBryant Ranch Prepack06b9f724-6425-4976-93eb-b9ca343ef5cf2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077867
application number: ANDA077867
SevofluraneSEVOFLURANEPiramal Critical Care Inc3dbab949-6ab7-4040-9c81-314e5bb61d412025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077867
application number: ANDA077867

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200243sevoflurane 100 % Inhalation SolutionPSNfedfd1db-7e32-44b2-89e9-7bb00ee6810d29
997625Sojourn 100 % Inhalation SolutionPSNfedfd1db-7e32-44b2-89e9-7bb00ee6810d29
997625sevoflurane 1000 MG/ML Inhalation Solution [Sojourn]SBDfedfd1db-7e32-44b2-89e9-7bb00ee6810d29
200243sevoflurane 1000 MG/ML Inhalation SolutionSCDfedfd1db-7e32-44b2-89e9-7bb00ee6810d29
200243sevoflurane 100 % Inhalation SolutionSYfedfd1db-7e32-44b2-89e9-7bb00ee6810d29
997625Sojourn 100 % Inhalation SolutionSYfedfd1db-7e32-44b2-89e9-7bb00ee6810d29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66794-012-1066794001210100 mL in 1 BOTTLE, GLASS (66794-012-10) 100 ml2010-04-130000-00-00NoNoCurrent
66794-012-2566794001225250 mL in 1 BOTTLE, GLASS (66794-012-25) 250 ml2010-04-130000-00-00NoNoCurrent