Dexamethasone Sodium Phosphate

Product NDC: 63323-165
11-digit product format: 633230165
Labeler code: 63323
Product ID: 63323-165_9dd90418-e564-4bc5-9077-506a1c2c1bce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXAMETHASONE SODIUM PHOSPHATE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA084916
Marketing category: ANDA
Marketing start: 2000-09-07
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
A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084916-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084916-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`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	A084916-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084916-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084916-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084916-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084916-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084916-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084916-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084916-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084916-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084916-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084916-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084916-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084916-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084916-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084916-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084916-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084916-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084916-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084916-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084916-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084916-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084916-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084916-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084916-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084916-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084916-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084916-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084916-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084916-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084916-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084916-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084916-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084916-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084916-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084916-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084916-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084916-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084916-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084916-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084916-001	AP	1	`cb3db0bc1861…`

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	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
2b626a48-c7aa-4443-9164-a08ff069ccd1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d4d7da1a-7fd4-628e-cdae-89e749b1c534	Product name	7	20260127
75f7e47b-8736-a182-fc44-22aca8d79689	Product name	2	20251211
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2	Product name	6	20250516
5dad6767-dcd1-b0da-8727-7f3f7bc3a435	Product name	2	20250303
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
e42f429b-c4e5-0402-e1c5-730154df4060	Product name	4	20240205
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
38d4de13-64b3-4057-b91c-4b5126962341	Product name	1	20220516
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
5da98533-f072-406b-9e1b-6ac19eca9926	Product name	1	20210622
306b993e-3140-4823-ad5e-88b708f9d2ac	Product name	1	20210510
089e0644-1ea8-8654-4113-39f960dd57d5	Product name	3	20210115
a831e694-3663-4a83-82be-6c309429f750	Product name	2	20200608
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
5331c9c8-f64b-11e6-ccf1-071c477fcb0b	Product name	7	20190612
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
9f64e0dc-109c-9660-8e0e-91ec987b3817	Product name	6	20171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002f	Product name	1	20171204
8de20f81-8411-4cf1-a8b2-03404ee56d01	Product name	3	20171109
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
a5f1a68c-0352-4f34-46a3-9b4eed239ed8	Product name	2	20160819
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
355b2224-0895-7135-83f5-d099a6a82a0a	Product name	1	20140508
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
55be6b50-8cc0-f0f1-74a1-3416a91193aa	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cf	Product name	1	20140508
89b93c13-4be8-69f3-b33b-63e64feffb9b	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	SPL version
63323-165-01	Dexamethasone Sodium Phosphate	25 in 1 TRAY	INJECTION, SOLUTION	25	6
63323-165-02	Dexamethasone Sodium Phosphate	1 mL in 1 VIAL	INJECTION, SOLUTION	1	6
63323-165-03	Dexamethasone Sodium Phosphate	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	6
63323-165-05	Dexamethasone Sodium Phosphate	25 in 1 TRAY	INJECTION, SOLUTION	25	6
63323-165-11	Dexamethasone Sodium Phosphate	1 mL in 1 VIAL	INJECTION, SOLUTION	1	6
63323-165-13	Dexamethasone Sodium Phosphate	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	6
63323-165-30	Dexamethasone Sodium Phosphate	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30	6
63323-165-30	Dexamethasone Sodium Phosphate	1 in 1 BOX	INJECTION, SOLUTION	1	6
63323-165-51	Dexamethasone Sodium Phosphate	25 in 1 TRAY	INJECTION, SOLUTION	25	6
63323-165-53	Dexamethasone Sodium Phosphate	25 in 1 TRAY	INJECTION, SOLUTION	25	6
63323-165-16	Dexamethasone Sodium Phosphate	25 in 1 TRAY	INJECTION, SOLUTION	25	3
63323-165-16	Dexamethasone Sodium Phosphate	1 mL in 1 VIAL	INJECTION, SOLUTION	1	3
63323-165-26	Dexamethasone Sodium Phosphate	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	3
63323-165-26	Dexamethasone Sodium Phosphate	25 in 1 TRAY	INJECTION, SOLUTION	25	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-165-01	ML - Milliliter	63323-165	6e55c862-8987-4ecc-afdf-cad7b61b3eb2	1	2012-07-24
63323-165-02	ML - Milliliter	63323-165	38751704-0982-48a7-b8bf-53f9c59ee7a9	1	2018-07-03
63323-165-03	ML - Milliliter	63323-165	ed621c97-a49f-4003-a974-a4568f47123c	1	2018-07-03
63323-165-05	ML - Milliliter	63323-165	3c40a72c-671a-4d8a-9dfa-08dca3e814aa	1	2012-07-24
63323-165-16	ML - Milliliter	63323-165	87515e12-3d2d-464e-bc28-2538e57da224	1	2015-12-02
63323-165-26	ML - Milliliter	63323-165	bf356dfa-c1e8-45bf-9a23-bf3d1b08a1b8	1	2015-12-02
63323-165-30	ML - Milliliter	63323-165	69e24d2d-3cee-4ab7-ba96-806aa053bfa2	1	2012-07-24

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 [FRESENIUS KABI USA, LLC]	3
DEXAMETHASONE SODIUM PHOSPHATE	ACTIVE INGREDIENT	AI9376Y64P	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]	3
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
SODIUM SULFITE	INACTIVE INGREDIENT	VTK01UQK3G	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [CARDINAL HEALTH]	3
SODIUM SULFITE	INACTIVE INGREDIENT	VTK01UQK3G	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
DEXAMETHASONE SODIUM PHOSPHATE	ACTIVE INGREDIENT	AI9376Y64P	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM SULFITE	INACTIVE INGREDIENT	VTK01UQK3G	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-165	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6	Current NDC, Legacy NDC, 10 package rows	20240915_2b626a48-c7aa-4443-9164-a08ff069ccd1.zip
63323-165	DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3	Current NDC, Legacy NDC, 4 package rows	20241019_4fedef4f-ec96-4f36-b2f0-01e243e3b89e.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 · 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	Fresenius Kabi USA, LLC	2b626a48-c7aa-4443-9164-a08ff069ccd1	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084916 application number: ANDA084916 ndc (product): 63323-165
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Cardinal Health 107, LLC	6d3cbd54-93ef-40fe-b15a-7a4f52dc5f71	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084916 application number: ANDA084916
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	3c05089c-5a25-40c3-9abc-b2e40696bcdc	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084916 application number: ANDA084916
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	4fedef4f-ec96-4f36-b2f0-01e243e3b89e	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084916 application number: ANDA084916 ndc (product): 63323-165
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Phlow Corporation	02d25ab8-8f51-452b-b944-f569fbae36fe	2024-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084916 application number: ANDA084916
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	94cb045b-5801-db32-e053-2a95a90a93ef	2022-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084916 application number: ANDA084916

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
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	3c05089c-5a25-40c3-9abc-b2e40696bcdc	19
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	3c05089c-5a25-40c3-9abc-b2e40696bcdc	19
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	3c05089c-5a25-40c3-9abc-b2e40696bcdc	19
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	6d3cbd54-93ef-40fe-b15a-7a4f52dc5f71	12
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	6d3cbd54-93ef-40fe-b15a-7a4f52dc5f71	12
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	6d3cbd54-93ef-40fe-b15a-7a4f52dc5f71	12
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	a928b3ca-2408-425e-9dda-1ef84243d56c	10
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	a928b3ca-2408-425e-9dda-1ef84243d56c	10
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	a928b3ca-2408-425e-9dda-1ef84243d56c	10
1812194	dexAMETHasone sodium phosphate 4 MG in 1 ML Injection	PSN	2b626a48-c7aa-4443-9164-a08ff069ccd1	6
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	2b626a48-c7aa-4443-9164-a08ff069ccd1	6
1812194	1 ML dexamethasone phosphate 4 MG/ML Injection	SCD	2b626a48-c7aa-4443-9164-a08ff069ccd1	6
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	2b626a48-c7aa-4443-9164-a08ff069ccd1	6
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	2b626a48-c7aa-4443-9164-a08ff069ccd1	6
1812194	dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML Injection	SY	2b626a48-c7aa-4443-9164-a08ff069ccd1	6
1812194	dexAMETHasone sodium phosphate 4 MG in 1 ML Injection	PSN	84fffebe-8468-42be-adab-6220e737499a	4
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	84fffebe-8468-42be-adab-6220e737499a	4
797544	isopropyl alcohol 70 % Medicated Pad	PSN	84fffebe-8468-42be-adab-6220e737499a	4
2480108	Kenalog 40 MG in 1 ML Injection	PSN	84fffebe-8468-42be-adab-6220e737499a	4
1792144	triamcinolone acetonide 40 MG in 1 ML Injection	PSN	84fffebe-8468-42be-adab-6220e737499a	4
2480108	1 ML triamcinolone acetonide 40 MG/ML Injection [Kenalog]	SBD	84fffebe-8468-42be-adab-6220e737499a	4
1812194	1 ML dexamethasone phosphate 4 MG/ML Injection	SCD	84fffebe-8468-42be-adab-6220e737499a	4
1792144	1 ML triamcinolone acetonide 40 MG/ML Injection	SCD	84fffebe-8468-42be-adab-6220e737499a	4
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	84fffebe-8468-42be-adab-6220e737499a	4
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	84fffebe-8468-42be-adab-6220e737499a	4
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	84fffebe-8468-42be-adab-6220e737499a	4
1812194	dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML Injection	SY	84fffebe-8468-42be-adab-6220e737499a	4
797544	isopropyl alcohol 70 % Medicated Pad	SY	84fffebe-8468-42be-adab-6220e737499a	4
797544	isopropyl alcohol 70 % Topical Cloth	SY	84fffebe-8468-42be-adab-6220e737499a	4
797544	isopropyl alcohol 70 % Topical Swab	SY	84fffebe-8468-42be-adab-6220e737499a	4
2480108	Kenalog 40 MG per 1 ML Injection	SY	84fffebe-8468-42be-adab-6220e737499a	4
1792144	triamcinolone acetonide 40 MG per 1 ML Injection	SY	84fffebe-8468-42be-adab-6220e737499a	4
1812194	dexAMETHasone sodium phosphate 4 MG in 1 ML Injection	PSN	bb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c1	3
1812194	dexAMETHasone sodium phosphate 4 MG in 1 ML Injection	PSN	4fedef4f-ec96-4f36-b2f0-01e243e3b89e	3
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	bb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c1	3
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	4fedef4f-ec96-4f36-b2f0-01e243e3b89e	3
1116927	dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution	PSN	94cb045b-5801-db32-e053-2a95a90a93ef	3
797544	isopropyl alcohol 70 % Medicated Pad	PSN	bb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c1	3
1812194	1 ML dexamethasone phosphate 4 MG/ML Injection	SCD	4fedef4f-ec96-4f36-b2f0-01e243e3b89e	3
1812194	1 ML dexamethasone phosphate 4 MG/ML Injection	SCD	bb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c1	3
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	94cb045b-5801-db32-e053-2a95a90a93ef	3
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	4fedef4f-ec96-4f36-b2f0-01e243e3b89e	3
1116927	dexamethasone phosphate 4 MG/ML Injectable Solution	SCD	bb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c1	3
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	bb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c1	3
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	94cb045b-5801-db32-e053-2a95a90a93ef	3
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	4fedef4f-ec96-4f36-b2f0-01e243e3b89e	3
1116927	dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution	SY	bb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c1	3
1812194	dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML Injection	SY	4fedef4f-ec96-4f36-b2f0-01e243e3b89e	3
1812194	dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML Injection	SY	bb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c1	3
797544	isopropyl alcohol 70 % Medicated Pad	SY	bb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c1	3
797544	isopropyl alcohol 70 % Topical Cloth	SY	bb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c1	3
797544	isopropyl alcohol 70 % Topical Swab	SY	bb133ea1-0fae-4f15-a1d2-a5b5c8e2c6c1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-165-01	63323016501	25 VIAL in 1 TRAY (63323-165-01) / 1 mL in 1 VIAL (63323-165-02)	25 vial	2000-09-07	0000-00-00	No	No	Current
63323-165-02	63323016502	1 mL in 1 VIAL	1 ml					Historical
63323-165-03	63323016503	5 mL in 1 VIAL, MULTI-DOSE	5 ml					Historical
63323-165-05	63323016505	25 VIAL, MULTI-DOSE in 1 TRAY (63323-165-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-03)		2000-09-07	0000-00-00	No	No	Current
63323-165-11	63323016511	1 mL in 1 VIAL	1 ml					Historical
63323-165-13	63323016513	5 mL in 1 VIAL, MULTI-DOSE	5 ml					Historical
63323-165-16	63323016516	25 VIAL in 1 TRAY (63323-165-16) / 1 mL in 1 VIAL	25 vial	2000-09-07	0000-00-00	No	No	Current
63323-165-26	63323016526	25 VIAL, MULTI-DOSE in 1 TRAY (63323-165-26) / 5 mL in 1 VIAL, MULTI-DOSE		2000-09-07	0000-00-00	No	No	Current
63323-165-30	63323016530	1 VIAL, MULTI-DOSE in 1 BOX (63323-165-30) / 30 mL in 1 VIAL, MULTI-DOSE		2000-09-07	0000-00-00	No	No	Current
63323-165-51	63323016551	25 VIAL in 1 TRAY (63323-165-51) / 1 mL in 1 VIAL (63323-165-11)	25 vial	2025-02-17		No	No	Current
63323-165-53	63323016553	25 VIAL, MULTI-DOSE in 1 TRAY (63323-165-53) / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-13)		2025-02-17		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Sodium Phosphate Injection, USP	Fresenius Kabi USA, LLC	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	7
Dexamethasone Sodium Phosphate Injection, USP	Cardinal Health 107, LLC	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	13
Dexamethasone Sodium Phosphate Injection, USP	A-S Medication Solutions	2025-01-09	HUMAN PRESCRIPTION DRUG LABEL	19
Dexamethasone Sodium Phosphate Injection, USP	Fresenius Kabi USA, LLC	2024-10-14	HUMAN PRESCRIPTION DRUG LABEL	3
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 20 mg/5 mL (4 mg/mL) 5mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2022-12-10	HUMAN PRESCRIPTION DRUG LABEL	3
Cortaren Corticosteroid/Anti-Inflammatory System	IT3 Medical LLC	2022-02-24	HUMAN PRESCRIPTION DRUG LABEL	4
Neuromaquel Neuroma/Anti-Inflammatory System	IT3 Medical LLC	2022-02-24	HUMAN PRESCRIPTION DRUG LABEL	3
Dexamethasone Sodium Phosphate Injection, USP	A-S Medication Solutions	2021-02-16	Human Prescription Drug Label	10
Dexamethasone Sodium Phosphate Injection, USP	NuCare Pharmaceuticals,Inc.	2018-09-27	HUMAN PRESCRIPTION DRUG LABEL	1
Dexamethasone Sodium Phosphate Injection USP	REMEDYREPACK INC.	2017-11-28	HUMAN PRESCRIPTION DRUG LABEL	1
Dexamethasone Sodium Phosphate Injection USP	REMEDYREPACK INC.	2017-07-18	HUMAN PRESCRIPTION DRUG LABEL	1