Dexamethasone

Product NDC: 68071-3588
11-digit product format: 680713588
Labeler code: 68071
Product ID: 68071-3588_3b2d9344-a30a-844a-e063-6294a90ae9f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA215604
Marketing category: ANDA
Marketing start: 2023-08-07
Substance: DEXAMETHASONE
Active strength: 4 mg/1
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215604-001	DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08
A215604-002	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08
A215604-003	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08
A215604-004	DEXAMETHASONE	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05
A215604-005	DEXAMETHASONE	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A215604-001	AB
A215604-002	AB
A215604-003	AB
A215604-004	AB
A215604-005	AB

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 3 · 117 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	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 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	A215604-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215604-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXAMETHASONE	4 mg/1

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197582	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
141e16a7-1f3d-3943-e063-6294a90ac5a9	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	SPL version
68071-3588-1	Dexamethasone	10 in 1 BOTTLE	TABLET	10	3
68071-3588-6	Dexamethasone	6 in 1 BOTTLE	TABLET	6	3
68071-3588-8	Dexamethasone	8 in 1 BOTTLE	TABLET	8	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3588	DEXAMETHASONE TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 3 package rows	20241204_141e16a7-1f3d-3943-e063-6294a90ac5a9.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals, Inc.	c4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	REMEDYREPACK INC.	8c5375a7-7a0d-4af0-8b86-bc87698ac3d1	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	141e16a7-1f3d-3943-e063-6294a90ac5a9	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604 ndc (product): 68071-3588
Dexamethasone	DEXAMETHASONE	Direct_Rx	fade983c-81fb-df94-e053-6394a90a7560	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	Direct_Rx	044d7898-4ab6-a0b3-e063-6294a90acdba	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	American Health Packaging	23deb5f1-d357-45af-9851-d1249bdfa6dd	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	710ce0fc-78b3-402d-a2ca-e5eda09f3211	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	c75360d3-2e4f-4620-a8f0-db28b1aa704b	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	17f56402-331e-2e3d-e063-6394a90acc0e	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	NorthStar Rx LLC	05c77a4c-c508-babd-e063-6294a90a450a	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	ANI Pharmaceuticals, Inc.	fe8cf911-84ef-47be-acb8-0501b546299b	2024-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604

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
197582	dexAMETHasone 4 MG Oral Tablet	PSN	141e16a7-1f3d-3943-e063-6294a90ac5a9	3
197582	dexamethasone 4 MG Oral Tablet	SCD	141e16a7-1f3d-3943-e063-6294a90ac5a9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3588-1	68071358801	10 TABLET in 1 BOTTLE (68071-3588-1)	10 tablet	2024-12-02	No	No	Current
68071-3588-6	68071358806	6 TABLET in 1 BOTTLE (68071-3588-6)	6 tablet	2024-03-20	No	No	Current
68071-3588-8	68071358808	8 TABLET in 1 BOTTLE (68071-3588-8)	8 tablet	2025-07-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2025-07-30	HUMAN PRESCRIPTION DRUG LABEL	3