Suprane

Product NDC: 52584-641
11-digit product format: 525840641
Labeler code: 52584
Product ID: 52584-641_a7f8ad5a-504c-4e9d-9e1f-c690052fa6ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desflurane
Dosage form: LIQUID
Route: RESPIRATORY (INHALATION)
Labeler: General Injectables & Vaccines, Inc
Application: NDA020118
Marketing category: NDA
Marketing start: 2012-04-25
Marketing end: 2025-01-31
Substance: DESFLURANE
Active strength: 240 mL/240mL
Pharmacologic classes: General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52584-641		D	Discontinued by firm	2026-08-17
excluded package	package	52584-641	52584-641-24	D	Discontinued by firm	2026-08-17
excluded package	package	52584-641	52584-641-64	D	Discontinued by firm	2026-08-17

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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52584-641-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52584-641-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52584-641-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52584-641-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52584-641-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52584-641-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52584-641-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52584-641-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52584-641-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52584-641-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52584-641-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52584-641-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52584-641-24	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52584-641-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52584-641-24	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52584-641-24	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52584-641-24	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52584-641-24	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N020118-001	SUPRANE	DESFLURANE	100%	LIQUID / INHALATION		RLD, RS	1992-09-18

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	N020118-001	SUPRANE	100%	LIQUID / INHALATION		RLD, RS	1992-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020118-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020118-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020118-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020118-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020118-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020118-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020118-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020118-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020118-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020118-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020118-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020118-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020118-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020118-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020118-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020118-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020118-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020118-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020118-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020118-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020118-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020118-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020118-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020118-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020118-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020118-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020118-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020118-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020118-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020118-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020118-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020118-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020118-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020118-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020118-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020118-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020118-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020118-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020118-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020118-001	AN	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Desflurane	ACTIVE INGREDIENT	CRS35BZ94Q	SUPRANE (DESFLURANE) LIQUID [GENERAL INJECTABLES & VACCINES, INC]	4
Desflurane	ACTIVE MOIETY	CRS35BZ94Q	SUPRANE (DESFLURANE) LIQUID [GENERAL INJECTABLES & VACCINES, INC]	4

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Suprane	DESFLURANE	Henry Schein, Inc.	a3e4c8e5-bff0-4a8f-8401-e9866c846ee2	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020118 application number: NDA020118
SUPRANE	DESFLURANE	Baxter Healthcare Corporation	7f977eb6-c7c4-4dc5-ab3b-07414dbe5da5	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020118 application number: NDA020118
SUPRANE	DESFLURANE	Baxter Healthcare Corporation	3fe3d468-d283-4dd0-a1a7-29291a9b2d0b	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020118 application number: NDA020118
Suprane	DESFLURANE	Baxter Healthcare Corporation	efbb228b-7b38-4176-8bae-826103178c35	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020118 application number: NDA020118

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CRS35BZ94Q	DESFLURANE	57041-67-5	DESFLURANE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-641-64	52584064164	1 BOTTLE in 1 BAG (52584-641-64) > 240 mL in 1 BOTTLE	1 bottle	2012-04-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Suprane - General Injectables & Vaccines, Inc	General Injectables & Vaccines, Inc	2022-12-27	HUMAN PRESCRIPTION DRUG LABEL	12