Itraconazole

Product NDC: 70518-2872
11-digit product format: 705182872
Labeler code: 70518
Product ID: 70518-2872_d7829254-0ca3-ce62-e053-2995a90a2617
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Itraconazole
Dosage form: CAPSULE, COATED PELLETS
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA208591
Marketing category: ANDA
Marketing start: 2020-09-09
Marketing end: 0000-00-00
Substance: ITRACONAZOLE
Active strength: 100 mg/1
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	70518-2872		D	Discontinued by firm	2026-08-17
excluded package	package	70518-2872	70518-2872-0	D	Discontinued by firm	2026-08-17
excluded package	package	70518-2872	70518-2872-1	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 · 16 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	70518-2872-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2872-0	`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	70518-2872-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2872-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2872-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2872-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2872-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2872-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2872-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2872-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2872-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2872-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2872-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2872-0	`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
A208591-001	ITRACONAZOLE	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB		2017-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208591-001	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`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	A208591-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208591-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208591-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208591-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208591-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208591-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208591-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208591-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208591-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208591-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208591-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208591-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208591-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208591-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208591-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208591-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208591-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208591-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208591-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208591-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208591-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208591-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208591-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208591-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208591-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208591-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208591-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208591-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208591-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208591-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208591-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208591-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208591-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208591-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208591-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208591-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208591-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208591-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208591-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208591-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2872-0	2022-02-08	C162847	48780-1	d6a99b39-fb3c-a426-e053-dadaa90af4c2	Itraconazole Capsules 100 mg
70518-2872-0	2022-01-28	C162847	48780-1	d6a99b39-fb3c-a426-e053-dadaa90af4c2	Itraconazole Capsules 100 mg

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Itraconazole	ITRACONAZOLE	Ascend Laboratories, LLC	349ffcf4-b2cd-4c93-9411-13c39275b8f3	2025-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208591 application number: ANDA208591
Itraconazole	ITRACONAZOLE	NorthStar RxLLC	46732a10-1f0d-4022-9689-256c44683e96	2023-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208591 application number: ANDA208591

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
304NUG5GF4	ITRACONAZOLE	84625-61-6	ITRACONAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2872-0	70518287200	14 CAPSULE, COATED PELLETS in 1 BOTTLE, PLASTIC (70518-2872-0)	2020-09-09	0000-00-00	No	No	Current