Econazole Nitrate

Product NDC: 52565-022
Requested package NDC: 52565-022-15
11-digit product format: 525650022
Labeler code: 52565
Product ID: 52565-022_4fbee603-de52-4aec-b5eb-8cf29a8a01db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Econazole Nitrate
Dosage form: CREAM
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA076574
Marketing category: ANDA
Marketing start: 2013-08-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52565-022	52565-022-15	I	Inactivated by FDA		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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
e3a04dc3-1a9e-4fba-b2b4-a18279351082	Product name	2	20180620
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
aa7deb41-117b-479c-8362-130fd1c222de	Product name	1	20160112

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52565-022-15	2023-01-30	C162847	48780-1	f386c649-bb85-0266-e053-dadaa90a7c1a	Econazole Nitrate Cream 1%
52565-022-30	2023-01-30	C162847	48780-1	f386c649-bb85-0266-e053-dadaa90a7c1a	Econazole Nitrate Cream 1%
52565-022-85	2023-01-30	C162847	48780-1	f386c649-bb85-0266-e053-dadaa90a7c1a	Econazole Nitrate Cream 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52565-022-15	Econazole Nitrate	1 in 1 CARTON	CREAM	1	6
52565-022-15	Econazole Nitrate	15 g in 1 TUBE	CREAM	15	6
52565-022-30	Econazole Nitrate	30 g in 1 TUBE	CREAM	30	6
52565-022-30	Econazole Nitrate	1 in 1 CARTON	CREAM	1	6
52565-022-85	Econazole Nitrate	85 g in 1 TUBE	CREAM	85	6
52565-022-85	Econazole Nitrate	1 in 1 CARTON	CREAM	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-022-15	GM - Gram	52565-022	e59f81fc-edcb-42b9-afc2-4d6523ca44f5	1	2013-08-02
52565-022-30	GM - Gram	52565-022	e1bc6e2b-0fad-4a0c-abc6-797cb1e58812	1	2013-08-02
52565-022-85	GM - Gram	52565-022	38cf1b76-c9ab-4ac9-9ec6-680759ae83e7	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Econazole Nitrate	ACTIVE INGREDIENT	H438WYN10E	ECONAZOLE NITRATE CREAM [IGI LABS, INC.]	1
Econazole	ACTIVE MOIETY	6Z1Y2V4A7M	ECONAZOLE NITRATE CREAM [IGI LABS, INC.]	1
Benzoic Acid	INACTIVE INGREDIENT	8SKN0B0MIM	ECONAZOLE NITRATE CREAM [IGI LABS, INC.]	1
Butylated Hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	ECONAZOLE NITRATE CREAM [IGI LABS, INC.]	1
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	ECONAZOLE NITRATE CREAM [IGI LABS, INC.]	1
PEG-5 Oleate	INACTIVE INGREDIENT	0240V77G50	ECONAZOLE NITRATE CREAM [IGI LABS, INC.]	1
Pegoxol 7 Stearate	INACTIVE INGREDIENT	3EW5AXE5X5	ECONAZOLE NITRATE CREAM [IGI LABS, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	ECONAZOLE NITRATE CREAM [IGI LABS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-022	ECONAZOLE NITRATE CREAM [TELIGENT PHARMA, INC.]	6	Legacy NDC, 6 package rows	20210918_51fd5746-8313-4f68-b929-8481ad8ca241.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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857366	econazole nitrate 1 % Topical Cream	PSN	51fd5746-8313-4f68-b929-8481ad8ca241	6
857366	econazole nitrate 10 MG/ML Topical Cream	SCD	51fd5746-8313-4f68-b929-8481ad8ca241	6
857366	econazole nitrate 1 % Topical Cream	SY	51fd5746-8313-4f68-b929-8481ad8ca241	6
857366	econazole nitrate 10 MG per 1 GM Topical Cream	SY	51fd5746-8313-4f68-b929-8481ad8ca241	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-022-15	52565002215	1 TUBE in 1 CARTON (52565-022-15) > 15 g in 1 TUBE	1 tube	2013-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Econazole Nitrate Cream 1%	Preferred Pharmaceuticals Inc.	2022-05-10	HUMAN PRESCRIPTION DRUG LABEL	5
Econasil (Econazole Nitrate Cream 1%, Gauze Pads, Silicone Tape Roll)	PURETEK CORPORATION \| Teligent Pharma, Inc.	2021-03-30	HUMAN PRESCRIPTION DRUG LABEL	4
Econavix	Primary Pharmaceuticals, Inc. \| Teligent Pharma, Inc. \| Rainbow Gold	2020-12-23	HUMAN PRESCRIPTION DRUG LABEL	1
Triamazole	PureTek Corporation \| Teligent Pharma, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL	1
Zolpak	PureTek Corporation \| Teligent Pharma, Inc.	2020-11-10	HUMAN PRESCRIPTION DRUG LABEL	2
Econazole Nitrate Cream 1%	Teligent Pharma, Inc.	2018-07-19	HUMAN PRESCRIPTION DRUG LABEL	6