Dexamethasone Sodium Phosphate

Product NDC: 70518-4372
11-digit product format: 705184372
Labeler code: 70518
Product ID: 70518-4372_3867dcb2-3f87-722f-e063-6294a90abd06
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone Sodium Phosphate
Dosage form: INJECTION, SOLUTION
Route: INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler: REMEDYREPACK INC.
Application: ANDA215654
Marketing category: ANDA
Marketing start: 2025-06-25
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP		2021-08-04
A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP		2023-09-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A215654-001	AP
A215654-002	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 · 53 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	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 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	A215654-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215654-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215654-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215654-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215654-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215654-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215654-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215654-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215654-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215654-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215654-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215654-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215654-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215654-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215654-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215654-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215654-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215654-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215654-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215654-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215654-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215654-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215654-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215654-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215654-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215654-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215654-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215654-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215654-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215654-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215654-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215654-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215654-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215654-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215654-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215654-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215654-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215654-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215654-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215654-001	AP	1	`a72a2bbeb626…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
11f10a47-1c42-40e4-89d8-bb000fef497c	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	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
70518-4372-0	Dexamethasone Sodium Phosphate	25 in 1 CARTON	INJECTION, SOLUTION	25		1
70518-4372-1	Dexamethasone Sodium Phosphate	1 mL in 1 VIAL	INJECTION, SOLUTION	1		1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC.	41eb3b4a-3386-ebfa-e063-6394a90a4dba	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215654 application number: ANDA215654
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	REMEDYREPACK INC.	11f10a47-1c42-40e4-89d8-bb000fef497c	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215654 application number: ANDA215654 ndc (product): 70518-4372
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sagent Pharmaceuticals	4680d517-ed5a-4137-819c-122ee962a464	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215654 application number: ANDA215654
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Gland Pharma Limited	c9d9ab76-6bc6-433d-aad7-8d49064ed745	2024-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215654 application number: ANDA215654

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
1812194	dexAMETHasone sodium phosphate 4 MG in 1 ML Injection	PSN	11f10a47-1c42-40e4-89d8-bb000fef497c	1
1812194	1 ML dexamethasone phosphate 4 MG/ML Injection	SCD	11f10a47-1c42-40e4-89d8-bb000fef497c	1
1812194	dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML Injection	SY	11f10a47-1c42-40e4-89d8-bb000fef497c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4372-0	70518437200	25 VIAL in 1 CARTON (70518-4372-0) / 1 mL in 1 VIAL (70518-4372-1)	25 vial	2025-06-25	No	No	Current
70518-4372-1	70518437201	1 mL in 1 VIAL	1 ml				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP	REMEDYREPACK INC.	2025-06-25	HUMAN PRESCRIPTION DRUG LABEL	1