Home NDC 66794-020 Isoflurane
Product NDC 66794-020
11-digit product format 667940020
Labeler code 66794
Product ID 66794-020_43ec760c-2344-b345-e063-6394a90a6293
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 2013-11-13
Substance ISOFLURANE
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-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 · 42 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 2026-08-18 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…2022-09-29 23:25 UTC 2022-09 A074416-001 ISOFLURANE 99.9% LIQUID / INHALATION AN 1994-09-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Isoflurane
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 542347 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66794-020-10 Isoflurane 100 mL in 1 BOTTLE LIQUID 100 15 66794-020-25 Isoflurane 250 mL in 1 BOTTLE, GLASS LIQUID 250 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66794-020 ISOFLURANE LIQUID [PIRAMAL CRITICAL CARE INC] 13 Current NDC, Legacy NDC, 2 package rows 20230217_13c9c37a-0c3d-450a-a61e-d2796818b18f.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 66794-020-01 66794002001 100 mL in 1 BOTTLE (66794-020-01) 100 ml 2013-11-13 0000-00-00 No No Current 66794-020-10 66794002010 100 mL in 1 BOTTLE (66794-020-10) 100 ml 2013-11-13 0000-00-00 No No Current 66794-020-25 66794002025 250 mL in 1 BOTTLE, GLASS (66794-020-25) 250 ml 2013-11-13 0000-00-00 No No Current