Dexamethasone Sodium Phosphate

Product NDC: 85766-214
Requested package NDC: 85766-214-10
11-digit product format: 857660214
Labeler code: 85766
Product ID: 85766-214_563b20bd-9015-3146-e063-6294a90a0fd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone Sodium Phosphate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Sportpharm LLC
Application: ANDA040802
Marketing category: ANDA
Marketing start: 2011-05-11
Substance: DEXAMETHASONE SODIUM PHOSPHATE
Active strength: 10 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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
A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP		2008-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040802-001	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040802-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040802-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040802-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040802-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040802-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040802-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040802-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040802-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040802-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040802-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040802-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040802-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040802-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040802-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040802-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040802-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040802-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040802-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040802-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040802-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040802-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040802-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040802-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040802-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040802-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040802-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040802-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040802-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040802-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040802-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040802-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040802-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040802-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040802-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040802-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040802-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040802-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040802-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040802-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040802-001	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Dexamethasone Sodium Phosphate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXAMETHASONE SODIUM PHOSPHATE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
AI9376Y64P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309696	Internal RxNorm lookup
1116927	Internal RxNorm lookup
1812194	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a8aee11f-c928-41ef-8df8-e6d8b355536c	Available on FDA.report

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sportpharm LLC	a8aee11f-c928-41ef-8df8-e6d8b355536c	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040802 application number: ANDA040802 ndc (package): 85766-214-10 ndc (product): 85766-214 ndc11 (package): 85766021410
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Henry Schein, Inc.	6ded4eac-3f86-4cf8-a05f-3e9c52984d6c	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040802 application number: ANDA040802
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Asclemed USA, Inc.	36854dbc-22f2-5df9-e063-6394a90ad934	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040802 application number: ANDA040802
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Mylan Institutional LLC	dff598e8-e662-411f-978d-4ba3fb8ef7db	2024-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040802 application number: ANDA040802
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	69339a97-99dd-7297-e053-2991aa0a7fb8	2023-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040802 application number: ANDA040802
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Mylan Institutional LLC	836f8017-d023-410b-8515-ec776e73ca59	2019-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040802 application number: ANDA040802

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AI9376Y64P	DEXAMETHASONE SODIUM PHOSPHATE	2392-39-4	DEXAMETHASONE SODIUM PHOSPHATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85766-214-10	85766021410	10 VIAL in 1 CARTON (85766-214-10) / 10 mL in 1 VIAL (85766-214-01)	10 vial	2026-07-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Sodium Phosphate Injection, USP	Sportpharm LLC	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	1