Dexamethasone Sodium Phosphate

Product NDC: 67457-421
11-digit product format: 674570421
Labeler code: 67457
Product ID: 67457-421_dd5c82b6-a194-462c-9626-34a9b410cfea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone Sodium Phosphate
Dosage form: INJECTION, SOLUTION
Route: INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler: Mylan Institutional LLC
Application: ANDA040803
Marketing category: ANDA
Marketing start: 2011-05-11
Substance: DEXAMETHASONE SODIUM PHOSPHATE
Active strength: 4 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG 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
A040803-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040803-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040803-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040803-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040803-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040803-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040803-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040803-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040803-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040803-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040803-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040803-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040803-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040803-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040803-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040803-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040803-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040803-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040803-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040803-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040803-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040803-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040803-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040803-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040803-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040803-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040803-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040803-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040803-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040803-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040803-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040803-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040803-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040803-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040803-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040803-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040803-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040803-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040803-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040803-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040803-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040803-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dexamethasone Sodium Phosphate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXAMETHASONE SODIUM PHOSPHATE	4 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
dff598e8-e662-411f-978d-4ba3fb8ef7db	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67457-421-00	Dexamethasone Sodium Phosphate	30 mL in 1 VIAL	INJECTION, SOLUTION	30		8
67457-421-30	Dexamethasone Sodium Phosphate	25 in 1 CARTON	INJECTION, SOLUTION	25		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-421-00	ML - Milliliter	67457-421	74cb3546-73b8-492a-9143-de38d25e150f	1	2014-06-03
67457-421-30	ML - Milliliter	67457-421	4817700b-ead1-4d86-8bdd-42e62e91e912	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXAMETHASONE SODIUM PHOSPHATE	ACTIVE INGREDIENT	AI9376Y64P	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
ANHYDROUS TRISODIUM CITRATE	INACTIVE INGREDIENT	RS7A450LGA	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
DEXAMETHASONE SODIUM PHOSPHATE	ACTIVE INGREDIENT	AI9376Y64P	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC]	2
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC]	2
ANHYDROUS TRISODIUM CITRATE	INACTIVE INGREDIENT	RS7A450LGA	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-421	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	8	Current NDC, Legacy NDC, 2 package rows	20240321_dff598e8-e662-411f-978d-4ba3fb8ef7db.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 · 12 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): 040803 application number: ANDA040803
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Henry Schein, Inc.	c464ffde-f64e-4716-92d2-720a10793248	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040803 application number: ANDA040803
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	ProPharma Distribution	384206f5-75ed-9bd2-e063-6294a90a5038	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040803 application number: ANDA040803
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	ProPharma Distribution	42c879cc-38dc-c9bc-e063-6294a90a204d	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040803 application number: ANDA040803
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): 040803 application number: ANDA040803
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	d21f3055-8a8a-4797-93e2-c8f582cbdae1	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040803 application number: ANDA040803
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): 040803 application number: ANDA040803 ndc (product): 67457-421
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	86091483-2053-5da8-e053-2a91aa0a6f45	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040803 application number: ANDA040803
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	81a28bdb-b186-8047-e053-2a91aa0a4e0a	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040803 application number: ANDA040803
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	81a0503c-39fe-1c67-e053-2a91aa0a5b8f	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040803 application number: ANDA040803
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Asclemed USA, Inc.	b2ce414a-3b1f-4533-bb3a-18594529dead	2020-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040803 application number: ANDA040803
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): 040803 application number: ANDA040803

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309696	dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	dff598e8-e662-411f-978d-4ba3fb8ef7db	8
1812194	dexAMETHasone sodium phosphate 4 MG in 1 ML Injection	PSN	dff598e8-e662-411f-978d-4ba3fb8ef7db	8
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	dff598e8-e662-411f-978d-4ba3fb8ef7db	8
1812194	1 ML dexamethasone phosphate 4 MG/ML Injection	SCD	dff598e8-e662-411f-978d-4ba3fb8ef7db	8
309696	dexamethasone phosphate 10 MG/ML Injectable Solution	SCD	dff598e8-e662-411f-978d-4ba3fb8ef7db	8
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	dff598e8-e662-411f-978d-4ba3fb8ef7db	8
309696	dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable Solution	SY	dff598e8-e662-411f-978d-4ba3fb8ef7db	8
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	dff598e8-e662-411f-978d-4ba3fb8ef7db	8
1812194	dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML Injection	SY	dff598e8-e662-411f-978d-4ba3fb8ef7db	8
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	384206f5-75ed-9bd2-e063-6294a90a5038	3
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	c464ffde-f64e-4716-92d2-720a10793248	3
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	384206f5-75ed-9bd2-e063-6294a90a5038	3
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	c464ffde-f64e-4716-92d2-720a10793248	3
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	384206f5-75ed-9bd2-e063-6294a90a5038	3
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	c464ffde-f64e-4716-92d2-720a10793248	3
309696	dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	36854dbc-22f2-5df9-e063-6394a90ad934	2
1812194	dexAMETHasone sodium phosphate 4 MG in 1 ML Injection	PSN	36854dbc-22f2-5df9-e063-6394a90ad934	2
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	81a0503c-39fe-1c67-e053-2a91aa0a5b8f	2
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	36854dbc-22f2-5df9-e063-6394a90ad934	2
1812194	1 ML dexamethasone phosphate 4 MG/ML Injection	SCD	36854dbc-22f2-5df9-e063-6394a90ad934	2
309696	dexamethasone phosphate 10 MG/ML Injectable Solution	SCD	36854dbc-22f2-5df9-e063-6394a90ad934	2
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	81a0503c-39fe-1c67-e053-2a91aa0a5b8f	2
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	36854dbc-22f2-5df9-e063-6394a90ad934	2
309696	dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable Solution	SY	36854dbc-22f2-5df9-e063-6394a90ad934	2
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	81a0503c-39fe-1c67-e053-2a91aa0a5b8f	2
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	36854dbc-22f2-5df9-e063-6394a90ad934	2
1812194	dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML Injection	SY	36854dbc-22f2-5df9-e063-6394a90ad934	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-421-00	67457042100	30 mL in 1 VIAL	30 ml					Historical
67457-421-30	67457042130	25 VIAL in 1 CARTON (67457-421-30) / 30 mL in 1 VIAL (67457-421-00)	25 vial	2011-05-11	0000-00-00	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
Dexamethasone Sodium Phosphate injection, USP Rx only	Henry Schein, Inc.	2026-01-02	HUMAN PRESCRIPTION DRUG LABEL	3
Dexamethasone Sodium Phosphate Injection, USP	ProPharma Distribution	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	3
Dexamethasone Sodium Phosphate Injection, USP	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-06-06	HUMAN PRESCRIPTION DRUG LABEL	2
Dexamethasone Sodium Phosphate Injection, USP	REMEDYREPACK INC.	2024-04-24	HUMAN PRESCRIPTION DRUG LABEL	4
Dexamethasone Sodium Phosphate Injection, USP	Mylan Institutional LLC	2024-03-05	HUMAN PRESCRIPTION DRUG LABEL	8
Dexamethasone Sodium Phosphate Injection, USP	Medical Purchasing Solutions, LLC	2023-05-16	HUMAN PRESCRIPTION DRUG LABEL	2
Dexamethasone Sodium Phosphate	General Injectables and Vaccines, Inc	2021-04-29	HUMAN PRESCRIPTION DRUG LABEL	6