Dexamethasone

Product NDC: 69452-277
11-digit product format: 694520277
Labeler code: 69452
Product ID: 69452-277_2f9dcbaf-165e-5594-e063-6394a90a9dc5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Bionpharma Inc.,
Application: ANDA217001
Marketing category: ANDA
Marketing start: 2023-08-01
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217001-001	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2023-04-19
A217001-002	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB		2023-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217001-001	AB
A217001-002	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 2 · 44 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	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A217001-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217001-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217001-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217001-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217001-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217001-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217001-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217001-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217001-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217001-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217001-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217001-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217001-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217001-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217001-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217001-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217001-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217001-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217001-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217001-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217001-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217001-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217001-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217001-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217001-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217001-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217001-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217001-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217001-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217001-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217001-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217001-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217001-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217001-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217001-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217001-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217001-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217001-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217001-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217001-002	AB	1	`a67488948f0b…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197582	Internal RxNorm lookup
197583	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
3166db4f-66a5-496a-a194-3cc01b7347d3	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
69452-277-20	Dexamethasone	100 in 1 BOTTLE	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-277-20	EA - Each	69452-277	1a8dc2c9-139e-4497-96cb-b6400161833c	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-277	DEXAMETHASONE TABLET [BIONPHARMA INC.,]	3	Current NDC, 1 package rows	20250308_3166db4f-66a5-496a-a194-3cc01b7347d3.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	DEXAMETHASONE	Sportpharm LLC	a37486b9-4323-41fc-ac7e-869d95dc9568	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	429d0d32-a1ff-481b-b4e9-c0b17b3610a1	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Advanced Rx of Tennessee, LLC	348f5a56-978d-4272-e063-6294a90afdb6	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Bionpharma Inc.,	3166db4f-66a5-496a-a194-3cc01b7347d3	2025-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001 ndc (product): 69452-277
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	b883860c-27ba-4bac-8ae3-4cf4d82d5071	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	e652b041-2a0b-4bcd-a420-5d026302edbb	2024-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001

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	3166db4f-66a5-496a-a194-3cc01b7347d3	3
197583	dexAMETHasone 6 MG Oral Tablet	PSN	3166db4f-66a5-496a-a194-3cc01b7347d3	3
197582	dexamethasone 4 MG Oral Tablet	SCD	3166db4f-66a5-496a-a194-3cc01b7347d3	3
197583	dexamethasone 6 MG Oral Tablet	SCD	3166db4f-66a5-496a-a194-3cc01b7347d3	3
197582	dexAMETHasone 4 MG Oral Tablet	PSN	348f5a56-978d-4272-e063-6294a90afdb6	1
197582	dexAMETHasone 4 MG Oral Tablet	PSN	429d0d32-a1ff-481b-b4e9-c0b17b3610a1	1
197582	dexAMETHasone 4 MG Oral Tablet	PSN	b883860c-27ba-4bac-8ae3-4cf4d82d5071	1
197582	dexAMETHasone 4 MG Oral Tablet	PSN	e652b041-2a0b-4bcd-a420-5d026302edbb	1
197582	dexamethasone 4 MG Oral Tablet	SCD	348f5a56-978d-4272-e063-6294a90afdb6	1
197582	dexamethasone 4 MG Oral Tablet	SCD	429d0d32-a1ff-481b-b4e9-c0b17b3610a1	1
197582	dexamethasone 4 MG Oral Tablet	SCD	b883860c-27ba-4bac-8ae3-4cf4d82d5071	1
197582	dexamethasone 4 MG Oral Tablet	SCD	e652b041-2a0b-4bcd-a420-5d026302edbb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69452-277-20	69452027720	100 TABLET in 1 BOTTLE (69452-277-20)	100 tablet	2023-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Tablets, USP Rx only	Sportpharm LLC	2026-07-17	HUMAN PRESCRIPTION DRUG LABEL	1
Dexamethasone Tablets, USP Rx only	Proficient Rx LP	2025-11-01	HUMAN PRESCRIPTION DRUG LABEL	1
Dexamethasone Tablets, USP Rx only	Advanced Rx of Tennessee, LLC	2025-05-07	HUMAN PRESCRIPTION DRUG LABEL	1
Dexamethasone Tablets, USP Rx only	Bionpharma Inc., \| Steril-Gene Life Sciences Private Limited	2025-03-05	HUMAN PRESCRIPTION DRUG LABEL	3
Dexamethasone Tablets, USP 4mg and 6 mg Rx only	Preferred Pharmaceuticals Inc.	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL	1
Dexamethasone Tablets, USP 4mg and 6 mg Rx only	Bryant Ranch Prepack	2024-09-23	HUMAN PRESCRIPTION DRUG LABEL	1