TopiDex

Product NDC: 70112-555
11-digit product format: 701120555
Labeler code: 70112
Product ID: 70112-555_69333734-6371-4310-e053-2a91aa0a611c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexamethasone surgical combo kit
Dosage form: KIT
Labeler: Topicare Management, LLC
Application: ANDA040491
Marketing category: ANDA
Marketing start: 2018-04-16
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70112-555		I	Inactivated by FDA		2026-08-17
excluded package	package	70112-555	70112-555-02	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 · 42 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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`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	70112-555-02	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70112-555-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70112-555-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70112-555-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	70112-555-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	70112-555-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	70112-555-02	`9bebd1f3094a…`	`5416666fcb17…`

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
A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040491-001	AP

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	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`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	A040491-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040491-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040491-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040491-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040491-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040491-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040491-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040491-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040491-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040491-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040491-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040491-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040491-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040491-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040491-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040491-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040491-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040491-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040491-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040491-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040491-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040491-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040491-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040491-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040491-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040491-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040491-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040491-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040491-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040491-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040491-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040491-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040491-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040491-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040491-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040491-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040491-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040491-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040491-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040491-001	AP	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421
399647c0-db89-02d1-991c-0c17b584482c	Product name	1	20140508
3e9a6377-704f-dff7-b19f-56c98d40c444	Product name	1	20140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70112-555-02	2020-01-31	C162847	48780-1	9d75b9d0-2437-f424-e053-dadaa90a57ce	69333734-6370-4310-e053-2a91aa0a611c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67777-121-14	TopiDex	0.55 mL in 1 POUCH	SWAB	1.65 mL	0.7 mL in 1mL	1
70112-555-02	TopiDex	1 in 1 BOX	KIT	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70112-555-02	EA - Each	70112-555	b3088a4e-8c3a-40b9-8fd8-58a28274cc07	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70112-555	TOPIDEX (DEXAMETHASONE SURGICAL COMBO KIT) KIT [TOPICARE MANAGEMENT, LLC]	1	Legacy NDC, 2 package rows	20180418_69333734-6370-4310-e053-2a91aa0a611c.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	cca2c160-9188-48e8-9505-49a52388dcb7	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040491 application number: ANDA040491
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	7cbd9005-7df2-47ee-adb3-7244c1c69bc3	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040491 application number: ANDA040491
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sportpharm LLC	6c7ff5f7-5688-4fc4-9194-9e6b8e6fab59	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040491 application number: ANDA040491
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sportpharm LLC	56bdd2f3-ae94-4fd9-9d05-5b53263a09c1	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040491 application number: ANDA040491

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1812079	dexAMETHasone sodium phosphate 10 MG in 1 ML Injection	PSN	69333734-6370-4310-e053-2a91aa0a611c	1
797544	isopropyl alcohol 70 % Medicated Pad	PSN	69333734-6370-4310-e053-2a91aa0a611c	1
797730	povidone-iodine 10 % Medicated Pad	PSN	69333734-6370-4310-e053-2a91aa0a611c	1
1812079	1 ML dexamethasone phosphate 10 MG/ML Injection	SCD	69333734-6370-4310-e053-2a91aa0a611c	1
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	69333734-6370-4310-e053-2a91aa0a611c	1
797730	povidone-iodine 100 MG/ML Medicated Pad	SCD	69333734-6370-4310-e053-2a91aa0a611c	1
1812079	dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML Injection	SY	69333734-6370-4310-e053-2a91aa0a611c	1
797544	isopropyl alcohol 70 % Medicated Pad	SY	69333734-6370-4310-e053-2a91aa0a611c	1
797544	isopropyl alcohol 70 % Topical Cloth	SY	69333734-6370-4310-e053-2a91aa0a611c	1
797544	isopropyl alcohol 70 % Topical Swab	SY	69333734-6370-4310-e053-2a91aa0a611c	1
797730	povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad	SY	69333734-6370-4310-e053-2a91aa0a611c	1
797730	povidone-iodine 10 % Medicated Pad	SY	69333734-6370-4310-e053-2a91aa0a611c	1
797730	povidone-iodine 10 % Medicated Swabstick	SY	69333734-6370-4310-e053-2a91aa0a611c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67777-121-14	67777012114	0.55 mL in 1 POUCH	0.55 ml	Historical
70112-555-02	70112055502	1 in 1 BOX		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TopiDex - Topicare Management, LLC	Topicare Management, LLC	2018-04-06	HUMAN PRESCRIPTION DRUG LABEL	1