Application 012071

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DECADRON	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	DECADRON	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N012071-002	DECADRON	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N012071-004	DECADRON	DEXAMETHASONE SODIUM PHOSPHATE	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`

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 2 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Henry Schein, Inc.	6ded4eac-3f86-4cf8-a05f-3e9c52984d6c	2026-01-02	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	ce25183b-cd67-4997-8de9-df59b750883b	2025-12-24	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	ProPharma Distribution	384206f5-75ed-9bd2-e063-6294a90a5038	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	ProPharma Distribution	42c879cc-38dc-c9bc-e063-6294a90a204d	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	4dd55929-fe0a-4884-ae0d-6f9435920eb7	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	88d25d19-acff-477b-86c8-9797782045b8	2025-12-11	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Eugia US LLC	29947f67-7868-40af-8ad2-a61f7149b44c	2025-11-12	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	Eugia US LLC	ce7ad5a4-a9c5-42d6-87cc-ca16556208d2	2025-11-12	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DMT SUIK	DEXAMETHASONE SODIUM PHOSPHATE	Advanced Rx of Tennessee, LLC	43045630-8bf8-59ae-e063-6294a90a2ebe	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC.	41eb3b4a-3386-ebfa-e063-6394a90a4dba	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Henry Schein, Inc.	d9b935d5-1b4f-4a08-8d40-57f397368fef	2025-09-29	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Eugia US LLC	224c34c9-cadc-40cb-a9b7-a9772fd0208e	2025-07-17	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Asclemed USA, Inc.	36854dbc-22f2-5df9-e063-6394a90ad934	2025-06-06	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Armas Pharmaceuticals	0ce0211c-86fa-4056-b161-0950639df6d8	2025-04-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	Somerset Therapeutics, LLC	5a1b0266-90c8-4176-a6b0-c4204d3c604e	2025-02-14	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	3c05089c-5a25-40c3-9abc-b2e40696bcdc	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Somerset Therapeutics, LLC	2dcbf312-6f4b-439a-8e2f-dda61eeb2cab	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	9a426a16-19f8-567e-e053-2a95a90a0a5b	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Advanced Rx Pharmacy of Tennessee, LLC	f4d6c7c8-7a77-6a46-e053-2995a90a4411	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Civica, Inc.	d54a27f2-2af8-4f86-a7fd-453f6b1a9997	2024-12-26	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.