Dexamethasone

Product NDC: 0054-3177
11-digit product format: 000543177
Labeler code: 0054
Product ID: 0054-3177_286734bc-8329-4f44-a20b-610cf7b67591
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: SOLUTION
Route: ORAL
Labeler: Hikma Pharmaceuticals USA, Inc.
Application: ANDA088248
Marketing category: ANDA
Marketing start: 1983-09-01
Substance: DEXAMETHASONE
Active strength: .5 mg/5mL
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
A088248-001	DEXAMETHASONE	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL		RLD, RS	1983-09-01

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RS	1983-09-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RS	1983-09-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RS	1983-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RS	1983-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RS	1983-09-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RS	1983-09-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RS	1983-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RS	1983-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RS	1983-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RS	1983-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RS	1983-09-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088248-001	DEXAMETHASONE	0.5MG/5ML	SOLUTION / ORAL	RLD, RS	1983-09-01	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXAMETHASONE	.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7S5I7G3JQL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197577	Internal RxNorm lookup
197579	Internal RxNorm lookup
197580	Internal RxNorm lookup
197581	Internal RxNorm lookup
197582	Internal RxNorm lookup
197583	Internal RxNorm lookup
309684	Internal RxNorm lookup
309686	Internal RxNorm lookup
343033	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
b15200fb-1826-472b-a907-e677a272513b	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
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
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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	SPL version
0054-3177-57	Dexamethasone	240 mL in 1 BOTTLE, PLASTIC	SOLUTION	240	11
0054-3177-63	Dexamethasone	500 mL in 1 BOTTLE, PLASTIC	SOLUTION	500	11
0054-3177-57	Dexamethasone	240 mL in 1 BOTTLE, PLASTIC	SOLUTION	240	8
0054-3177-63	Dexamethasone	500 mL in 1 BOTTLE, PLASTIC	SOLUTION	500	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-3177-57	ML - Milliliter	0054-3177	4118491a-17f0-4d96-986f-219843bcb5ec	1	2012-07-24
0054-3177-63	ML - Milliliter	0054-3177	1d8da431-3bb8-4eed-aeeb-1dedebeb7733	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
citric acid	INACTIVE INGREDIENT	2968PHW8QP	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
cosmetic ochre	INACTIVE INGREDIENT		DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
D&C Yellow No. 10	INACTIVE INGREDIENT		DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
FD&C Blue No. 1	INACTIVE INGREDIENT		DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
FD&C Green No. 3	INACTIVE INGREDIENT		DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
FD&C Red No. 3	INACTIVE INGREDIENT		DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
FD&C Red No. 40	INACTIVE INGREDIENT		DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
FD&C Yellow No. 6	INACTIVE INGREDIENT		DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
flavoring	INACTIVE INGREDIENT		DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
lactose monohydrate	INACTIVE INGREDIENT		DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
methylparaben	INACTIVE INGREDIENT		DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
starch	INACTIVE INGREDIENT		DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
sucrose	INACTIVE INGREDIENT	C151H8M554	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
Yellow No. 6	INACTIVE INGREDIENT		DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION	8
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [ROXANE LABORATORIES, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-3177	DEXAMETHASONE TABLET DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE DEXAMETHASONE SOLUTION [HIKMA PHARMACEUTICALS USA, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20240308_b15200fb-1826-472b-a907-e677a272513b.zip
0054-3177	DEXAMETHASONE (DEXAMETHASONE) TABLET DEXAMETHASONE (DEXAMETHASONE) SOLUTION, CONCENTRATE DEXAMETHASONE (DEXAMETHASONE) SOLUTION [ROXANE LABORATORIES, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20071101_537B424A-3E07-4C81-978C-1AD99014032A.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Intensol	DEXAMETHASONE INTENSOL	Hikma Pharmaceuticals USA, Inc.	b15200fb-1826-472b-a907-e677a272513b	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088248 application number: ANDA088248 ndc (product): 0054-3177

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309686	dexAMETHasone 0.5 MG in 5 mL Oral Solution	PSN	b15200fb-1826-472b-a907-e677a272513b	11
197577	dexAMETHasone 0.5 MG Oral Tablet	PSN	b15200fb-1826-472b-a907-e677a272513b	11
343033	dexAMETHasone 0.75 MG Oral Tablet	PSN	b15200fb-1826-472b-a907-e677a272513b	11
309684	dexAMETHasone 1 MG in 1 mL Concentrate for Oral Solution	PSN	b15200fb-1826-472b-a907-e677a272513b	11
197579	dexAMETHasone 1 MG Oral Tablet	PSN	b15200fb-1826-472b-a907-e677a272513b	11
197580	dexAMETHasone 1.5 MG Oral Tablet	PSN	b15200fb-1826-472b-a907-e677a272513b	11
197581	dexAMETHasone 2 MG Oral Tablet	PSN	b15200fb-1826-472b-a907-e677a272513b	11
197582	dexAMETHasone 4 MG Oral Tablet	PSN	b15200fb-1826-472b-a907-e677a272513b	11
197583	dexAMETHasone 6 MG Oral Tablet	PSN	b15200fb-1826-472b-a907-e677a272513b	11
309686	dexamethasone 0.1 MG/ML Oral Solution	SCD	b15200fb-1826-472b-a907-e677a272513b	11
197577	dexamethasone 0.5 MG Oral Tablet	SCD	b15200fb-1826-472b-a907-e677a272513b	11
343033	dexamethasone 0.75 MG Oral Tablet	SCD	b15200fb-1826-472b-a907-e677a272513b	11
197579	dexamethasone 1 MG Oral Tablet	SCD	b15200fb-1826-472b-a907-e677a272513b	11
309684	dexamethasone 1 MG/ML Oral Solution	SCD	b15200fb-1826-472b-a907-e677a272513b	11
197580	dexamethasone 1.5 MG Oral Tablet	SCD	b15200fb-1826-472b-a907-e677a272513b	11
197581	dexamethasone 2 MG Oral Tablet	SCD	b15200fb-1826-472b-a907-e677a272513b	11
197582	dexamethasone 4 MG Oral Tablet	SCD	b15200fb-1826-472b-a907-e677a272513b	11
197583	dexamethasone 6 MG Oral Tablet	SCD	b15200fb-1826-472b-a907-e677a272513b	11
309686	dexamethasone 0.5 MG per 5 ML Oral Solution	SY	b15200fb-1826-472b-a907-e677a272513b	11
309684	dexamethasone 1 MG per 1 ML Concentrate for Oral Solution	SY	b15200fb-1826-472b-a907-e677a272513b	11
309686	dexamethasone 1 MG per 10 ML Oral Solution	SY	b15200fb-1826-472b-a907-e677a272513b	11
309686	dexAMETHasone 0.5 MG in 5 mL Oral Solution	PSN	537b424a-3e07-4c81-978c-1ad99014032a	8
197577	dexAMETHasone 0.5 MG Oral Tablet	PSN	537b424a-3e07-4c81-978c-1ad99014032a	8
343033	dexAMETHasone 0.75 MG Oral Tablet	PSN	537b424a-3e07-4c81-978c-1ad99014032a	8
309684	dexAMETHasone 1 MG in 1 mL Concentrate for Oral Solution	PSN	537b424a-3e07-4c81-978c-1ad99014032a	8
197579	dexAMETHasone 1 MG Oral Tablet	PSN	537b424a-3e07-4c81-978c-1ad99014032a	8
197580	dexAMETHasone 1.5 MG Oral Tablet	PSN	537b424a-3e07-4c81-978c-1ad99014032a	8
197581	dexAMETHasone 2 MG Oral Tablet	PSN	537b424a-3e07-4c81-978c-1ad99014032a	8
197582	dexAMETHasone 4 MG Oral Tablet	PSN	537b424a-3e07-4c81-978c-1ad99014032a	8
197583	dexAMETHasone 6 MG Oral Tablet	PSN	537b424a-3e07-4c81-978c-1ad99014032a	8
309686	dexamethasone 0.1 MG/ML Oral Solution	SCD	537b424a-3e07-4c81-978c-1ad99014032a	8
197577	dexamethasone 0.5 MG Oral Tablet	SCD	537b424a-3e07-4c81-978c-1ad99014032a	8
343033	dexamethasone 0.75 MG Oral Tablet	SCD	537b424a-3e07-4c81-978c-1ad99014032a	8
197579	dexamethasone 1 MG Oral Tablet	SCD	537b424a-3e07-4c81-978c-1ad99014032a	8
309684	dexamethasone 1 MG/ML Oral Solution	SCD	537b424a-3e07-4c81-978c-1ad99014032a	8
197580	dexamethasone 1.5 MG Oral Tablet	SCD	537b424a-3e07-4c81-978c-1ad99014032a	8
197581	dexamethasone 2 MG Oral Tablet	SCD	537b424a-3e07-4c81-978c-1ad99014032a	8
197582	dexamethasone 4 MG Oral Tablet	SCD	537b424a-3e07-4c81-978c-1ad99014032a	8
197583	dexamethasone 6 MG Oral Tablet	SCD	537b424a-3e07-4c81-978c-1ad99014032a	8
309686	dexamethasone 0.5 MG per 5 ML Oral Solution	SY	537b424a-3e07-4c81-978c-1ad99014032a	8
309684	dexamethasone 1 MG per 1 ML Concentrate for Oral Solution	SY	537b424a-3e07-4c81-978c-1ad99014032a	8
309686	dexamethasone 1 MG per 10 ML Oral Solution	SY	537b424a-3e07-4c81-978c-1ad99014032a	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-3177-57	00054317757	240 mL in 1 BOTTLE, PLASTIC (0054-3177-57)	240 ml	2007-11-01	0000-00-00	No	No	Current
0054-3177-63	00054317763	500 mL in 1 BOTTLE, PLASTIC (0054-3177-63)	500 ml	1983-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Tablets, USP Dexamethasone Oral Solution, USP and Dexamethasone Oral Solution, USP Intensol ™ (Concentrate)	Hikma Pharmaceuticals USA, Inc. \| West-Ward Columbus Inc.	2025-06-06	HUMAN PRESCRIPTION DRUG LABEL	11
Dexamethasone Oral Solution USP	Pharmaceutical Associates, Inc. \| West-Ward Columbus Inc.	2022-12-02	HUMAN PRESCRIPTION DRUG LABEL	2
Dexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)	Bryant Ranch Prepack	2020-07-21	HUMAN PRESCRIPTION DRUG LABEL	1004
DEXAMETHASONE Tablets USP, DEXAMETHASONE Oral Solution, and DEXAMETHASONE Intensol ™ Oral Solution (Concentrate)		2007-10-25	Human prescription drug label	8