Home NDC 66794-011-10 Terrell
Product NDC 66794-011
Requested package NDC 66794-011-10
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A074416-001 ISOFLURANE ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074416-001 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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 Terrell
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOFLURANE 1 mL/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CYS9AKD70P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 542347 Internal RxNorm lookup 542355 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 66794-011-10 2025-02-11 These highlights do not include all the information needed to use TERRELL™(ISOFLURANE, USP) safely and effectively. See full prescribing information for TERRELL™(ISOFLURANE, USP). TERRELL™ (ISOFLURANE, USP)liquid for inhalation Initial U.S. Approval: 1979 66794-011-25 2025-02-11 These highlights do not include all the information needed to use TERRELL™(ISOFLURANE, USP) safely and effectively. See full prescribing information for TERRELL™(ISOFLURANE, USP). TERRELL™ (ISOFLURANE, USP)liquid for inhalation Initial U.S. Approval: 1979 66794-011-10 2025-01-30 These highlights do not include all the information needed to use TERRELL™(ISOFLURANE, USP) safely and effectively. See full prescribing information for TERRELL™(ISOFLURANE, USP). TERRELL™ (ISOFLURANE, USP)liquid for inhalation Initial U.S. Approval: 1979 66794-011-25 2025-01-30 These highlights do not include all the information needed to use TERRELL™(ISOFLURANE, USP) safely and effectively. See full prescribing information for TERRELL™(ISOFLURANE, USP). TERRELL™ (ISOFLURANE, USP)liquid for inhalation Initial U.S. Approval: 1979
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66794-011-10 Terrell 100 mL in 1 BOTTLE, GLASS LIQUID 100 20 66794-011-25 Terrell 250 mL in 1 BOTTLE, GLASS LIQUID 250 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66794-011 TERRELL (ISOFLURANE) LIQUID [PIRAMAL CRITICAL CARE INC] 16 Current NDC, Legacy NDC, 2 package rows 20250214_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66794-011-10 66794001110 100 mL in 1 BOTTLE, GLASS (66794-011-10) 100 ml 2010-02-28 0000-00-00 No No Current