FORANE

Product NDC: 10019-360
11-digit product format: 100190360
Labeler code: 10019
Product ID: 10019-360_94e9746a-3202-4180-b5f7-e6882a2b3081
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isoflurane
Dosage form: INHALANT
Route: RESPIRATORY (INHALATION)
Labeler: Baxter Healthcare Corporation
Application: NDA017624
Marketing category: NDA
Marketing start: 1979-12-18
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

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
N017624-001	FORANE	ISOFLURANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017624-001	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	Source SHA-256
2026-08-18 06:07:40	2026-07	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017624-001	FORANE	99.9%	LIQUID / INHALATION	AN	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N017624-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017624-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017624-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017624-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017624-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017624-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017624-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017624-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017624-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017624-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017624-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017624-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017624-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017624-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017624-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017624-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017624-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017624-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017624-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017624-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017624-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017624-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017624-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017624-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017624-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017624-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017624-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017624-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017624-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017624-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017624-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017624-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017624-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017624-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017624-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017624-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017624-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017624-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017624-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017624-001	AN	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: FORANE
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
542358	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3d30eb8d-a62e-475f-926b-78ba63bee9c8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ac9629df-d32a-4233-ad61-63593097af8a	Product name	1	20220516

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10019-360-40	FORANE	6 in 1 PACKAGE	INHALANT	6	14
10019-360-40	FORANE	100 mL in 1 BOTTLE, GLASS	INHALANT	100	14
10019-360-60	FORANE	250 mL in 1 BOTTLE, GLASS	INHALANT	250	14
10019-360-60	FORANE	6 in 1 PACKAGE	INHALANT	6	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10019-360-40	ML - Milliliter	10019-360	124292cb-f9cf-4a81-8360-cfd5cd136009	1	2012-07-24
10019-360-60	ML - Milliliter	10019-360	d91cc76f-a835-454d-b37b-47b12fed0b16	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ISOFLURANE	ACTIVE INGREDIENT	CYS9AKD70P	FORANE (ISOFLURANE) INHALANT [BAXTER HEALTHCARE CORPORATION]	2
ISOFLURANE	ACTIVE MOIETY	CYS9AKD70P	FORANE (ISOFLURANE) INHALANT [BAXTER HEALTHCARE CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10019-360	FORANE (ISOFLURANE) INHALANT [BAXTER HEALTHCARE CORPORATION]	13	Current NDC, Legacy NDC, 4 package rows	20250507_3d30eb8d-a62e-475f-926b-78ba63bee9c8.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FORANE	ISOFLURANE	Baxter Healthcare Corporation	3d30eb8d-a62e-475f-926b-78ba63bee9c8	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017624 application number: NDA017624 ndc (product): 10019-360

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CYS9AKD70P	ISOFLURANE	26675-46-7	ISOFLURANE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
542358	Forane 99.9 % Inhalation Solution	PSN	3d30eb8d-a62e-475f-926b-78ba63bee9c8	14
542347	isoflurane 99.9 % Inhalation Solution	PSN	3d30eb8d-a62e-475f-926b-78ba63bee9c8	14
542358	isoflurane 999 MG/ML Inhalation Solution [Forane]	SBD	3d30eb8d-a62e-475f-926b-78ba63bee9c8	14
542347	isoflurane 999 MG/ML Inhalation Solution	SCD	3d30eb8d-a62e-475f-926b-78ba63bee9c8	14
542358	Forane 99.9 % Inhalation Solution	SY	3d30eb8d-a62e-475f-926b-78ba63bee9c8	14
542358	Forane 999 MG/ML Inhalation Solution	SY	3d30eb8d-a62e-475f-926b-78ba63bee9c8	14
542347	isoflurane 99.9 % Inhalation Solution	SY	3d30eb8d-a62e-475f-926b-78ba63bee9c8	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
10019-360-40	10019036040	6 BOTTLE, GLASS in 1 PACKAGE (10019-360-40) / 100 mL in 1 BOTTLE, GLASS	1979-12-18	0000-00-00	No	No	Current
10019-360-60	10019036060	6 BOTTLE, GLASS in 1 PACKAGE (10019-360-60) / 250 mL in 1 BOTTLE, GLASS	1979-12-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FORANE - Baxter Healthcare Corporation	Baxter Healthcare Corporation	2024-12-09	HUMAN PRESCRIPTION DRUG LABEL	14