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PHOSPHATE	INJECTABLE;INJECTION	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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PHOSPHATE	INJECTABLE;INJECTION	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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DEXAMETHASONE SODIUM PHOSPHATE	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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N012071-002	DECADRON	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`84e616aacf4f…`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N012071-004	DECADRON	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`84e616aacf4f…`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 3 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	Somerset Therapeutics, LLC	799028e2-c0e4-494f-89ff-1b786babc34a	2024-12-19	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	4fedef4f-ec96-4f36-b2f0-01e243e3b89e	2024-10-14	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	df77fab1-f58c-46db-e053-2a95a90a5416	2024-10-08	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Amneal Pharmaceuticals LLC	ddc82c42-2e6e-42a6-a30a-e41978e2f4da	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Amneal Pharmaceuticals LLC	ba18ba23-9ea3-4ce1-84ae-74e9151bb6a4	2024-07-29	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Gland Pharma Limited	c9d9ab76-6bc6-433d-aad7-8d49064ed745	2024-06-26	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Phlow Corporation	02d25ab8-8f51-452b-b944-f569fbae36fe	2024-06-25	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	18a70010-6cc5-19e2-e063-6394a90a0ea6	2024-05-28	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	d21f3055-8a8a-4797-93e2-c8f582cbdae1	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Mylan Institutional LLC	dff598e8-e662-411f-978d-4ba3fb8ef7db	2024-03-05	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	8e36534f-d64c-7e7b-e053-2995a90ad48e	2024-01-30	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	7da9da65-0c03-23e2-e053-2a91aa0a042f	2024-01-04	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	69339a97-99dd-7297-e053-2991aa0a7fb8	2023-06-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	69346605-dff6-1958-e053-2a91aa0a0e1a	2023-05-23	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	69344707-904d-7ba2-e053-2a91aa0a31f4	2023-05-23	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	69485218-9330-952d-e053-2a91aa0ad4e8	2023-05-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	86091483-2053-5da8-e053-2a91aa0a6f45	2023-05-16	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	81a28bdb-b186-8047-e053-2a91aa0a4e0a	2023-05-16	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	81a0503c-39fe-1c67-e053-2a91aa0a5b8f	2023-05-16	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	8effed8e-9a75-eb3e-e053-2a95a90a965b	2023-05-15	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.