Econazole Nitrate

Product NDC: 68788-8884
Requested package NDC: 68788-8884-3
11-digit product format: 687888884
Labeler code: 68788
Product ID: 68788-8884_2bd2a48e-cbef-4b14-a02f-9aa693cc4b47
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Econazole Nitrate
Dosage form: CREAM
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA076479
Marketing category: ANDA
Marketing start: 2006-08-08
Substance: ECONAZOLE NITRATE
Active strength: 10 mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076479-001	ECONAZOLE NITRATE	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076479-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076479-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076479-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076479-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076479-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076479-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076479-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076479-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076479-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076479-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076479-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076479-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076479-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076479-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076479-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076479-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076479-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076479-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076479-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076479-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076479-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076479-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076479-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076479-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076479-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076479-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076479-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076479-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076479-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076479-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076479-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076479-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076479-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076479-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076479-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076479-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076479-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076479-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076479-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076479-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076479-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Econazole Nitrate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ECONAZOLE NITRATE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
H438WYN10E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857366	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
2bd2a48e-cbef-4b14-a02f-9aa693cc4b47	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8884-3	Econazole Nitrate	30 g in 1 TUBE	CREAM	30		1
68788-8884-3	Econazole Nitrate	1 in 1 CARTON	CREAM	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8884-3	GM - Gram	68788-8884	63289362-95eb-41ea-8e91-84a58cb9379e	1	2025-07-08

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Econazole Nitrate	ECONAZOLE NITRATE	Bryant Ranch Prepack	790a86cc-e93b-4bb6-9b60-08b2c4587081	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479
Econazole Nitrate	ECONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	caa348ad-4832-435f-844d-55831f235cc0	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479
Econazole Nitrate	ECONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	2bd2a48e-cbef-4b14-a02f-9aa693cc4b47	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479 ndc (package): 68788-8884-3 ndc (product): 68788-8884 ndc11 (package): 68788888403
Econazole Nitrate	ECONAZOLE NITRATE	Bryant Ranch Prepack	b0c90efd-d9a2-4120-aa17-33a9d50f7347	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479
Econazole Nitrate	ECONAZOLE NITRATE	Bryant Ranch Prepack	ae173340-7611-4dc8-99a7-7669bc4fc97d	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479
Econazole Nitrate	ECONAZOLE NITRATE	Bryant Ranch Prepack	4ac65707-a8b2-45de-a3c6-89e3ea845124	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479
Econazole Nitrate	ECONAZOLE NITRATE	Padagis Israel Pharmaceuticals Ltd	3acc5e03-0339-4b23-945d-641746e81923	2023-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479

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	2bd2a48e-cbef-4b14-a02f-9aa693cc4b47	1
857366	econazole nitrate 10 MG/ML Topical Cream	SCD	2bd2a48e-cbef-4b14-a02f-9aa693cc4b47	1
857366	econazole nitrate 1 % Topical Cream	SY	2bd2a48e-cbef-4b14-a02f-9aa693cc4b47	1
857366	econazole nitrate 10 MG per 1 GM Topical Cream	SY	2bd2a48e-cbef-4b14-a02f-9aa693cc4b47	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8884-3	68788888403	1 TUBE in 1 CARTON (68788-8884-3) / 30 g in 1 TUBE	1 tube	2025-06-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Econazole Nitrate Cream, 1%	Preferred Pharmaceuticals Inc.	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	1