Econazole Nitrate

Product NDC: 21695-892
11-digit product format: 216950892
Labeler code: 21695
Product ID: 21695-892_28e567ca-dd90-45cc-894c-330437497531
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Econazole Nitrate
Dosage form: CREAM
Route: TOPICAL
Labeler: Rebel Distributors Corp
Application: ANDA076479
Marketing category: ANDA
Marketing start: 2004-06-23
Marketing end: 0000-00-00
Substance: ECONAZOLE NITRATE
Active strength: 10 mg/g
Pharmacologic classes: Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-892		I	Inactivated by FDA	2026-08-17
excluded package	package	21695-892	21695-892-15	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-892	21695-892-30	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-892	21695-892-85	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 2 · 88 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	21695-892-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-892-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-892-15	`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	21695-892-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-892-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-892-15	`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	21695-892-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-892-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-892-15	`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	21695-892-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-892-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-892-15	`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	21695-892-85	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-892-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-892-15	`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	21695-892-85	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-892-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-892-15	`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	21695-892-85	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-892-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-892-15	`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	21695-892-85	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-892-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-892-15	`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	21695-892-85	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-892-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-892-15	`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	21695-892-85	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-892-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-892-15	`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	21695-892-85	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-892-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-892-15	`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	21695-892-85	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-892-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-892-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-892-85	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-892-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-892-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-892-85	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-892-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-892-15	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-892-85	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-892-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-892-15	`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
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 · 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	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`caaa826d4ba7…`
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…`

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	A076479-001	AB	1	`caaa826d4ba7…`
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…`

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
21695-892-15	2019-09-24	C162847	48780-1	934fe258-4bc9-48b1-e053-8cdaa90a720a	Econazole Nitrate Cream, 1%
21695-892-30	2019-09-24	C162847	48780-1	934fe258-4bc9-48b1-e053-8cdaa90a720a	Econazole Nitrate Cream, 1%
21695-892-85	2019-09-24	C162847	48780-1	934fe258-4bc9-48b1-e053-8cdaa90a720a	Econazole Nitrate Cream, 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-892-15	Econazole Nitrate	15 g in 1 TUBE	CREAM	15	1
21695-892-30	Econazole Nitrate	30 g in 1 TUBE	CREAM	30	1
21695-892-85	Econazole Nitrate	85 g in 1 TUBE	CREAM	85	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-892-15	GM - Gram	21695-892	78917f2d-f0cc-41c4-a3bf-0ed845997c07	1	2012-07-24
21695-892-30	GM - Gram	21695-892	5ac57888-2353-4e56-b4a6-eb630b1c4c4c	1	2012-07-24
21695-892-85	GM - Gram	21695-892	6b1e09d1-fc40-440e-8b2c-8e398e63447d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ECONAZOLE NITRATE	ACTIVE INGREDIENT	H438WYN10E	ECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]	1
ECONAZOLE	ACTIVE MOIETY	6Z1Y2V4A7M	ECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]	1
benzoic acid	INACTIVE INGREDIENT	8SKN0B0MIM	ECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	ECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	ECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-892	ECONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 3 package rows	20110103_28e567ca-dd90-45cc-894c-330437497531.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 · 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
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	28e567ca-dd90-45cc-894c-330437497531	1
857366	econazole nitrate 10 MG/ML Topical Cream	SCD	28e567ca-dd90-45cc-894c-330437497531	1
857366	econazole nitrate 1 % Topical Cream	SY	28e567ca-dd90-45cc-894c-330437497531	1
857366	econazole nitrate 10 MG per 1 GM Topical Cream	SY	28e567ca-dd90-45cc-894c-330437497531	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-892-15	21695089215	15 g in 1 TUBE	15 g	Historical
21695-892-30	21695089230	30 g in 1 TUBE	30 g	Historical
21695-892-85	21695089285	85 g in 1 TUBE	85 g	Historical