Terrell

Product NDC
66794-011
11-digit product format
667940011
Labeler code
66794
Product ID
66794-011_4f586e17-8aee-9567-e063-6294a90a1aa2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoflurane
Dosage form
LIQUID
Route
RESPIRATORY (INHALATION)
Labeler
Piramal Critical Care, Inc.
Application
ANDA074416
Marketing category
ANDA
Marketing start
2010-02-28
Substance
ISOFLURANE
Active strength
1 mL/mL
Pharmacologic classes
General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66794-011-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66794-011-25DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66794-011-10UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66794-011-25UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66794-011-10UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66794-011-25UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66794-011-10UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66794-011-25UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage66794-011-01UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip6db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage66794-011-01UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage66794-011-01UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage66794-011-01UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage66794-011-01UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage66794-011-01UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…

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
A074416-001ISOFLURANEISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074416-001AN

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 06:07:402026-07A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-303f01610625f2…
2019-09-15 20:21 UTC2019-09A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074416-001ISOFLURANE99.9%LIQUID / INHALATIONAN1994-09-30e64feba35796…

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 06:07:402026-07A074416-001AN1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074416-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074416-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074416-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074416-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074416-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074416-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074416-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074416-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074416-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074416-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074416-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074416-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074416-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074416-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074416-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074416-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074416-001AN14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074416-001AN174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074416-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074416-001AN1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074416-001AN187673890dc5c…
2021-03-12 10:30 UTC2021-03A074416-001AN15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074416-001AN18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074416-001AN1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074416-001AN13f01610625f2…
2019-09-15 20:21 UTC2019-09A074416-001AN1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074416-001AN1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074416-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074416-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074416-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074416-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074416-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074416-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074416-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074416-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074416-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074416-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074416-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074416-001AN1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Terrell
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOFLURANE1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CYS9AKD70PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
542347Internal RxNorm lookup
542355Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dfb26527-c5ab-44d0-9236-24b1600e0db4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac9629df-d32a-4233-ad61-63593097af8aProduct name120220516

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66794-011-10Terrell100 mL in 1 BOTTLE, GLASSLIQUID10020
66794-011-25Terrell250 mL in 1 BOTTLE, GLASSLIQUID25020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66794-011-10ML - Milliliter66794-0114ac06a6a-20ca-45e7-b80c-b855205b2a1c12012-07-24
66794-011-25ML - Milliliter66794-01125f4168e-08cd-4253-9ea5-677923357ef712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOFLURANEACTIVE INGREDIENTCYS9AKD70PTERRELL (ISOFLURANE) LIQUID [PIRAMAL CRITICAL CARE INC]6
ISOFLURANEACTIVE MOIETYCYS9AKD70PTERRELL (ISOFLURANE) LIQUID [PIRAMAL CRITICAL CARE INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-011TERRELL (ISOFLURANE) LIQUID [PIRAMAL CRITICAL CARE INC]16Current NDC, Legacy NDC, 2 package rows20250214_dfb26527-c5ab-44d0-9236-24b1600e0db4.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerrellISOFLURANEPiramal Critical Care, Inc.dfb26527-c5ab-44d0-9236-24b1600e0db42026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074416
application number: ANDA074416
ndc (product): 66794-011
IsofluraneISOFLURANEPiramal Critical Care, Inc.13c9c37a-0c3d-450a-a61e-d2796818b18f2025-11-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074416
application number: ANDA074416

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
542347isoflurane 99.9 % Inhalation SolutionPSNdfb26527-c5ab-44d0-9236-24b1600e0db420
542355Terrell 99.9 % Inhalation SolutionPSNdfb26527-c5ab-44d0-9236-24b1600e0db420
542355isoflurane 999 MG/ML Inhalation Solution [Terrell]SBDdfb26527-c5ab-44d0-9236-24b1600e0db420
542347isoflurane 999 MG/ML Inhalation SolutionSCDdfb26527-c5ab-44d0-9236-24b1600e0db420
542347isoflurane 99.9 % Inhalation SolutionSYdfb26527-c5ab-44d0-9236-24b1600e0db420
542355Terrell 99.9 % Inhalation SolutionSYdfb26527-c5ab-44d0-9236-24b1600e0db420
542355Terrell 999 MG/ML Inhalation SolutionSYdfb26527-c5ab-44d0-9236-24b1600e0db420

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66794-011-1066794001110100 mL in 1 BOTTLE, GLASS (66794-011-10) 100 ml2010-02-280000-00-00NoNoCurrent
66794-011-2566794001125250 mL in 1 BOTTLE, GLASS (66794-011-25) 250 ml2010-02-280000-00-00NoNoCurrent