Dexlido-M Kit

Product NDC: 63187-348
11-digit product format: 631870348
Labeler code: 63187
Product ID: 63187-348_fd895819-b7d4-43bd-b804-f7b0722a00e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone Sodium Phosphate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine
Dosage form: KIT
Labeler: Proficient Rx LP
Application: ANDA040491
Marketing category: ANDA
Marketing start: 2014-07-25
Marketing end: 0000-00-00
Active strength: 0
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63187-348		I	Inactivated by FDA		2026-08-17
excluded package	package	63187-348	63187-348-01	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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-348-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-348-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63187-348-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63187-348-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63187-348-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63187-348-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63187-348-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63187-348-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63187-348-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63187-348-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63187-348-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63187-348-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63187-348-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63187-348-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63187-348-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63187-348-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63187-348-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63187-348-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63187-348-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63187-348-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63187-348-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63187-348-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435	Product name	2	20250303
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
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
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
5da98533-f072-406b-9e1b-6ac19eca9926	Product name	1	20210622
306b993e-3140-4823-ad5e-88b708f9d2ac	Product name	1	20210510
a831e694-3663-4a83-82be-6c309429f750	Product name	2	20200608
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
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
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
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
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
63187-348-01	2020-01-31	C162847	48780-1	9d75b9cf-d71e-f424-e053-dadaa90a57ce	Dexamethasone Sodium Phosphate Injection,USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-820-09	Dexlido-M Kit	5 mL in 1 POUCH	SWAB	15 mL	70 mL in 100mL	1
63187-348-01	Dexlido-M Kit	1 in 1 CARTON	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
63187-348-01	EA - Each	63187-348	0b0e67ae-a4f7-4ca6-9e95-123271ae7660	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Bupivacaine Hydrochloride	ACTIVE INGREDIENT	7TQO7W3VT8	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Dexamethasone Sodium Phosphate	ACTIVE INGREDIENT	AI9376Y64P	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Isopropyl Alcohol	ACTIVE INGREDIENT	ND2M416302	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Lidocaine Hydrochloride	ACTIVE INGREDIENT	V13007Z41A	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Povidone-Iodine	ACTIVE INGREDIENT	85H0HZU99M	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Bupivacaine	ACTIVE MOIETY	Y8335394RO	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Dexamethasone	ACTIVE MOIETY	7S5I7G3JQL	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Iodine	ACTIVE MOIETY	9679TC07X4	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Isopropyl Alcohol	ACTIVE MOIETY	ND2M416302	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Lidocaine	ACTIVE MOIETY	98PI200987	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Nonoxynol-9	INACTIVE INGREDIENT	48Q180SH9T	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-348	DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]	1	Legacy NDC, 2 package rows	20150407_fd895819-b7d4-43bd-b804-f7b0722a00e9.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
1725078	BUPivacaine HCl 0.25 % in 10 ML Injection	PSN	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1812079	dexAMETHasone sodium phosphate 10 MG in 1 ML Injection	PSN	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
797544	isopropyl alcohol 70 % Medicated Pad	PSN	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1737568	lidocaine HCl 1 % in 2 ML Injection	PSN	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1725079	Marcaine 0.25 % in 10 ML Injection	PSN	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
797730	povidone-iodine 10 % Medicated Pad	PSN	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1725079	10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]	SBD	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1812079	1 ML dexamethasone phosphate 10 MG/ML Injection	SCD	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1725078	10 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1737568	2 ML lidocaine hydrochloride 10 MG/ML Injection	SCD	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
797730	povidone-iodine 100 MG/ML Medicated Pad	SCD	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1725079	10 ML Marcaine 2.5 MG/ML Injection	SY	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1725078	bupivacaine HCl 0.25 % in 10 ML Injection	SY	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1812079	dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML Injection	SY	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
797544	isopropyl alcohol 70 % Medicated Pad	SY	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
797544	isopropyl alcohol 70 % Topical Cloth	SY	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
797544	isopropyl alcohol 70 % Topical Swab	SY	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1737568	lidocaine HCl 1 % per 2 ML Injection	SY	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1737568	lidocaine HCl 20 MG per 2 ML Injection	SY	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
1725079	Marcaine 0.25 % in 10 ML Injection	SY	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
797730	povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad	SY	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
797730	povidone-iodine 10 % Medicated Pad	SY	fd895819-b7d4-43bd-b804-f7b0722a00e9	1
797730	povidone-iodine 10 % Medicated Swabstick	SY	fd895819-b7d4-43bd-b804-f7b0722a00e9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53329-820-09	53329082009	5 mL in 1 POUCH	5 ml	Historical
63187-348-01	63187034801	1 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Sodium Phosphate Injection,USP	Proficient Rx LP	2014-08-05	HUMAN PRESCRIPTION DRUG LABEL	1