Dexamethasone

Product NDC: 53217-310
11-digit product format: 532170310
Labeler code: 53217
Product ID: 53217-310_be5921e9-99ec-47c5-af90-5ef03b4e8c33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: ELIXIR
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA084754
Marketing category: ANDA
Marketing start: 2017-05-19
Marketing end: 0000-00-00
Substance: DEXAMETHASONE
Active strength: 1 mg/5mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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	53217-310		I	Inactivated by FDA		2026-08-17
excluded package	package	53217-310	53217-310-01	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 · 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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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	53217-310-01	`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
A084754-001	DEXAMETHASONE	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084754-001	AA

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	Source SHA-256
2026-08-18 06:07:40	2026-07	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`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	A084754-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084754-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084754-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084754-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084754-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084754-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084754-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084754-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084754-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084754-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084754-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084754-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084754-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084754-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084754-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084754-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084754-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084754-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084754-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084754-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084754-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084754-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084754-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084754-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084754-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084754-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084754-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084754-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084754-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084754-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084754-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084754-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084754-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084754-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084754-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084754-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084754-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084754-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084754-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084754-001	AA	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
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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
53217-310-01	2020-01-31	C162847	48780-1	9d75b9d0-7efd-f424-e053-dadaa90a57ce	DEXAMETHASONE ELIXIR, USP 0.5 mg / 5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-310-01	Dexamethasone	237 mL in 1 BOTTLE, GLASS	ELIXIR	237		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-310-01	ML - Milliliter	53217-310	2bcb8be3-8c7f-45b4-9b44-69cda3a66c1e	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-310	DEXAMETHASONE ELIXIR [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20180522_4f6e8fd1-d3c5-46a3-b6ca-0748bfc59030.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXAMETHASONE	DEXAMETHASONE	Bryant Ranch Prepack	075717e3-be2a-4bb3-bead-492761bfb287	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084754 application number: ANDA084754
Dexamethasone	DEXAMETHASONE	ANI Pharmaceuticals, Inc.	5d9b22ca-c619-4ee3-98eb-74544d0d5cb3	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084754 application number: ANDA084754
Dexamethasone	DEXAMETHASONE	Kesin Pharma Corporation	43e2a24a-4465-5787-e063-6394a90a0b81	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084754 application number: ANDA084754
DEXAMETHASONE	DEXAMETHASONE	Kanchan Healthcare Inc	02f7bf9c-1aa3-4734-8a3e-1f49498055d7	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084754 application number: ANDA084754
Dexamethasone	DEXAMETHASONE	Marlex Pharmaceuticals, Inc	7b51ffce-ec64-4b49-8870-b9666537c541	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084754 application number: ANDA084754

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309686	dexAMETHasone 0.5 MG in 5 mL Oral Solution	PSN	4f6e8fd1-d3c5-46a3-b6ca-0748bfc59030	1
309686	dexamethasone 0.1 MG/ML Oral Solution	SCD	4f6e8fd1-d3c5-46a3-b6ca-0748bfc59030	1
309686	dexamethasone 0.5 MG per 5 ML Oral Solution	SY	4f6e8fd1-d3c5-46a3-b6ca-0748bfc59030	1
309686	dexamethasone 1 MG per 10 ML Oral Solution	SY	4f6e8fd1-d3c5-46a3-b6ca-0748bfc59030	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53217-310-01	53217031001	237 mL in 1 BOTTLE, GLASS	237 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXAMETHASONE ELIXIR, USP 0.5 mg / 5 mL	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-05-21	HUMAN PRESCRIPTION DRUG LABEL	1