Econazole Nitrate

Product NDC: 70512-029
11-digit product format: 705120029
Labeler code: 70512
Product ID: 70512-029_b8bc3272-6d40-59b8-e053-2995a90a2fd7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Econazole Nitrate
Dosage form: CREAM
Route: TOPICAL
Labeler: SOLA Pharmaceuticals
Application: ANDA076574
Marketing category: ANDA
Marketing start: 2019-02-04
Marketing end: 0000-00-00
Substance: ECONAZOLE NITRATE
Active strength: 10 mg/g
Pharmacologic classes: Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	70512-029		D	Discontinued by firm	2026-08-17
excluded package	package	70512-029	70512-029-30	D	Discontinued by firm	2026-08-17
excluded package	package	70512-029	70512-029-85	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 · 36 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	70512-029-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70512-029-30	`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	70512-029-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70512-029-30	`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	70512-029-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70512-029-30	`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	70512-029-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70512-029-30	`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	70512-029-85	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70512-029-30	`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	70512-029-85	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70512-029-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70512-029-85	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70512-029-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70512-029-85	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70512-029-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70512-029-85	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70512-029-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70512-029-85	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70512-029-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70512-029-85	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70512-029-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70512-029-85	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70512-029-30	`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
A076574-001	ECONAZOLE NITRATE	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB		2004-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076574-001	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	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL		2004-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076574-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	2004-12-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076574-001	AB	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076574-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076574-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076574-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076574-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076574-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076574-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076574-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076574-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076574-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076574-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076574-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076574-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076574-001	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A076574-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076574-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076574-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076574-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076574-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076574-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076574-001	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70512-029-30	GM - Gram	70512-029	5ddadc1c-eb51-4b21-8772-645a12663e8c	1	2019-03-12
70512-029-85	GM - Gram	70512-029	de3323d7-76d2-4017-8dcb-b88318698035	1	2019-03-12

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
Econazole Nitrate	ECONAZOLE NITRATE	Encube Ethicals, Inc.	64d82b8b-d749-4bfe-ba3e-25836d54e115	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076574 application number: ANDA076574

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H438WYN10E	ECONAZOLE NITRATE	24169-02-6	ECONAZOLE NITRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70512-029-30	70512002930	1 TUBE in 1 CARTON (70512-029-30) > 30 g in 1 TUBE	1 tube	2019-02-04	0000-00-00	No	No	Current