Dexamethasone

Product NDC: 70954-402
11-digit product format: 709540402
Labeler code: 70954
Product ID: 70954-402_75141974-8862-4da7-9253-a338cb1fdb84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA217696
Marketing category: ANDA
Marketing start: 2023-05-09
Substance: DEXAMETHASONE
Active strength: 2 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A217696-001	DEXAMETHASONE	DEXAMETHASONE	2MG	TABLET / ORAL	AB		2023-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217696-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217696-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217696-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217696-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217696-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217696-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217696-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217696-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217696-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217696-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217696-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217696-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217696-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217696-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217696-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217696-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217696-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217696-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217696-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217696-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217696-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217696-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217696-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217696-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217696-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXAMETHASONE	2 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197577	Internal RxNorm lookup
197580	Internal RxNorm lookup
197581	Internal RxNorm lookup
197582	Internal RxNorm lookup
197583	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
fe8cf911-84ef-47be-acb8-0501b546299b	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
70954-402-10	Dexamethasone	100 in 1 BOTTLE	TABLET	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70954-402-10	EA - Each	70954-402	0971ab41-c96c-4205-89ed-12cd5621fc3c	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70954-402	DEXAMETHASONE TABLET [ANI PHARMACEUTICALS, INC.]	5	Current NDC, 1 package rows	20240305_fe8cf911-84ef-47be-acb8-0501b546299b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Direct_Rx	0a0db8e7-8474-3d08-e063-6294a90af3f5	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217696 application number: ANDA217696
Dexamethasone	DEXAMETHASONE	American Health Packaging	23deb5f1-d357-45af-9851-d1249bdfa6dd	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217696 application number: ANDA217696
Dexamethasone	DEXAMETHASONE	NorthStar Rx LLC	05c77a4c-c508-babd-e063-6294a90a450a	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217696 application number: ANDA217696
Dexamethasone	DEXAMETHASONE	ANI Pharmaceuticals, Inc.	fe8cf911-84ef-47be-acb8-0501b546299b	2024-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217696 application number: ANDA217696 ndc (product): 70954-402

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
197577	dexAMETHasone 0.5 MG Oral Tablet	PSN	fe8cf911-84ef-47be-acb8-0501b546299b	5
343033	dexAMETHasone 0.75 MG Oral Tablet	PSN	fe8cf911-84ef-47be-acb8-0501b546299b	5
197580	dexAMETHasone 1.5 MG Oral Tablet	PSN	fe8cf911-84ef-47be-acb8-0501b546299b	5
197581	dexAMETHasone 2 MG Oral Tablet	PSN	23deb5f1-d357-45af-9851-d1249bdfa6dd	5
197581	dexAMETHasone 2 MG Oral Tablet	PSN	fe8cf911-84ef-47be-acb8-0501b546299b	5
197582	dexAMETHasone 4 MG Oral Tablet	PSN	23deb5f1-d357-45af-9851-d1249bdfa6dd	5
197582	dexAMETHasone 4 MG Oral Tablet	PSN	fe8cf911-84ef-47be-acb8-0501b546299b	5
197583	dexAMETHasone 6 MG Oral Tablet	PSN	23deb5f1-d357-45af-9851-d1249bdfa6dd	5
197583	dexAMETHasone 6 MG Oral Tablet	PSN	fe8cf911-84ef-47be-acb8-0501b546299b	5
197577	dexamethasone 0.5 MG Oral Tablet	SCD	fe8cf911-84ef-47be-acb8-0501b546299b	5
343033	dexamethasone 0.75 MG Oral Tablet	SCD	fe8cf911-84ef-47be-acb8-0501b546299b	5
197580	dexamethasone 1.5 MG Oral Tablet	SCD	fe8cf911-84ef-47be-acb8-0501b546299b	5
197581	dexamethasone 2 MG Oral Tablet	SCD	fe8cf911-84ef-47be-acb8-0501b546299b	5
197581	dexamethasone 2 MG Oral Tablet	SCD	23deb5f1-d357-45af-9851-d1249bdfa6dd	5
197582	dexamethasone 4 MG Oral Tablet	SCD	fe8cf911-84ef-47be-acb8-0501b546299b	5
197582	dexamethasone 4 MG Oral Tablet	SCD	23deb5f1-d357-45af-9851-d1249bdfa6dd	5
197583	dexamethasone 6 MG Oral Tablet	SCD	fe8cf911-84ef-47be-acb8-0501b546299b	5
197583	dexamethasone 6 MG Oral Tablet	SCD	23deb5f1-d357-45af-9851-d1249bdfa6dd	5
197581	dexAMETHasone 2 MG Oral Tablet	PSN	0a0db8e7-8474-3d08-e063-6294a90af3f5	3
197581	dexamethasone 2 MG Oral Tablet	SCD	0a0db8e7-8474-3d08-e063-6294a90af3f5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70954-402-10	70954040210	100 TABLET in 1 BOTTLE (70954-402-10)	100 tablet	2023-05-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone	Direct_Rx	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL	3
Dexamethasone Tablets, USP Rx Only 8471801/0924(F)	American Health Packaging	2024-12-05	HUMAN PRESCRIPTION DRUG LABEL	5
Dexamethasone Tablets, USP Rx only	ANI Pharmaceuticals, Inc. \| Novitium Pharma LLC	2024-03-04	Human Prescription Drug Label	5