Dexamethasone

Product NDC: 21695-382
11-digit product format: 216950382
Labeler code: 21695
Product ID: 21695-382_77a91c9e-f445-4227-8369-c69837563bb9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA084612
Marketing category: ANDA
Marketing start: 1978-07-19
Marketing end: 0000-00-00
Substance: DEXAMETHASONE
Active strength: 4 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-382		I	Inactivated by FDA	2026-08-17
excluded package	package	21695-382	21695-382-04	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-382	21695-382-08	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-382	21695-382-20	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-382	21695-382-60	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 · 110 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	21695-382-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-382-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-382-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-382-08	`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	21695-382-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-382-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-382-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-382-08	`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	21695-382-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-382-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-382-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-382-08	`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	21695-382-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-382-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-382-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-382-08	`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	21695-382-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-382-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-382-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-382-08	`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	21695-382-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-382-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-382-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-382-08	`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	21695-382-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-382-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-382-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-382-08	`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	21695-382-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-382-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-382-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-382-08	`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	21695-382-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-382-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-382-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-382-08	`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	21695-382-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-382-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-382-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-382-08	`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	21695-382-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-382-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-382-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-382-08	`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	21695-382-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-382-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-382-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-382-08	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084612-001	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982
A084612-002	DEXAMETHASONE	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
A084612-003	DEXAMETHASONE	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982
A084612-004	DEXAMETHASONE	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15
A084612-005	DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
A084612-006	DEXAMETHASONE	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A084612-007	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A084612-001	AB
A084612-002	AB
A084612-003	AB
A084612-004	AB
A084612-005	AB
A084612-006	AB
A084612-007	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 · 72 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	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-004	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-005	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-006	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-004	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-005	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-006	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-004	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-005	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-006	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-004	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-005	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-006	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5c6f7cd8ea54…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 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	A084612-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084612-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084612-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084612-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084612-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084612-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084612-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084612-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084612-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084612-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084612-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084612-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084612-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084612-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084612-001	AB	1	`5c6f7cd8ea54…`

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
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
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, Related label table
NDC	Related label
21695-382-04	DEXAMETHASONE Tablets USP,
21695-382-08	DEXAMETHASONE Tablets USP,
21695-382-20	DEXAMETHASONE Tablets USP,
21695-382-60	DEXAMETHASONE Tablets USP,

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-382-04	Dexamethasone	4 in 1 BOTTLE, PLASTIC	TABLET	4	2
21695-382-08	Dexamethasone	8 in 1 BOTTLE, PLASTIC	TABLET	8	2
21695-382-20	Dexamethasone	20 in 1 BOTTLE, PLASTIC	TABLET	20	2
21695-382-60	Dexamethasone	60 in 1 BOTTLE, PLASTIC	TABLET	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-382-04	EA - Each	21695-382	5b76dc5b-7406-41d9-9548-3aa37bfb176f	1	2012-07-24
21695-382-08	EA - Each	21695-382	824958f5-21b2-4745-95a0-d4513612853a	1	2012-07-24
21695-382-20	EA - Each	21695-382	9965eeed-11c8-4e55-99cd-d9477e916ada	1	2012-07-24
21695-382-60	EA - Each	21695-382	e2b93ad4-ee63-4263-b06b-cfc3064dd91e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]	2
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-382	DEXAMETHASONE TABLET [REBEL DISTRIBUTORS CORP]	2	Legacy NDC, 4 package rows	20120511_7658e4b2-5b0d-487a-a603-8fd264cb02ea.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	REMEDYREPACK INC.	f5c9b70b-b835-4f3b-9643-0aec50a0d3f2	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	89e1d458-7caa-430f-9c54-360889899a73	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Cardinal Health 107, LLC	bf8acfdb-8dc8-4a69-90b0-33c680c421d6	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Northwind Health Company, LLC	aa30086a-8551-413e-9cf2-6393093cfcfd	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Golden State Medical Supply, Inc.	a7455c92-41ce-4e87-e053-2995a90a610f	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone Intensol	DEXAMETHASONE INTENSOL	Hikma Pharmaceuticals USA, Inc.	b15200fb-1826-472b-a907-e677a272513b	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
DEXAMETHASONE	DEXAMETHASONE	Direct Rx	cc7140de-a205-f675-e053-2995a90ac22b	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	99296e80-3ca6-4430-9ef7-adca357c31b3	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Doc Rx	f1c30431-554b-4161-9d8c-5795c689e0bd	2021-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	89e570c9-3e64-433b-9779-b94332f2b5ef	2020-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612

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
197579	dexAMETHasone 1 MG Oral Tablet	PSN	7658e4b2-5b0d-487a-a603-8fd264cb02ea	2
197581	dexAMETHasone 2 MG Oral Tablet	PSN	7658e4b2-5b0d-487a-a603-8fd264cb02ea	2
197582	dexAMETHasone 4 MG Oral Tablet	PSN	7658e4b2-5b0d-487a-a603-8fd264cb02ea	2
197579	dexamethasone 1 MG Oral Tablet	SCD	7658e4b2-5b0d-487a-a603-8fd264cb02ea	2
197581	dexamethasone 2 MG Oral Tablet	SCD	7658e4b2-5b0d-487a-a603-8fd264cb02ea	2
197582	dexamethasone 4 MG Oral Tablet	SCD	7658e4b2-5b0d-487a-a603-8fd264cb02ea	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-382-04	21695038204	4 in 1 BOTTLE, PLASTIC	Historical
21695-382-08	21695038208	8 in 1 BOTTLE, PLASTIC	Historical
21695-382-20	21695038220	20 in 1 BOTTLE, PLASTIC	Historical
21695-382-60	21695038260	60 in 1 BOTTLE, PLASTIC	Historical