dexamethasone

Product NDC: 68788-8293
11-digit product format: 687888293
Labeler code: 68788
Product ID: 68788-8293_0af63cdb-85ed-4dda-86ec-9ac2fa29e989
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA215106
Marketing category: ANDA
Marketing start: 2022-11-29
Substance: DEXAMETHASONE
Active strength: 6 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-8293	68788-8293-1	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A215106-001	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2021-10-14
A215106-002	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB		2021-10-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215106-001	AB
A215106-002	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 · 66 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	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A215106-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215106-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215106-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215106-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215106-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215106-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215106-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215106-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215106-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215106-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215106-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215106-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215106-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215106-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215106-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215106-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215106-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215106-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215106-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215106-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215106-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215106-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215106-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215106-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215106-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215106-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215106-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215106-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215106-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215106-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215106-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215106-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215106-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215106-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215106-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215106-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215106-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215106-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215106-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215106-002	AB	1	`6a51e52b5d6a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215106-001	CGT	2022-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215106-002	CGT	2022-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215106-001	CGT	2022-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215106-002	CGT	2022-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215106-001	CGT	2022-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215106-002	CGT	2022-04-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215106-001	CGT	2022-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215106-002	CGT	2022-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215106-001	CGT	2022-04-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215106-002	CGT	2022-04-19	`782e0a99824c…`
2023-01-26 05:58 UTC	2023-01	A215106-001	CGT	2022-04-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215106-002	CGT	2022-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215106-001	CGT	2022-04-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215106-002	CGT	2022-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215106-001	CGT	2022-04-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A215106-002	CGT	2022-04-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215106-001	CGT	2022-04-20	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A215106-002	CGT	2022-04-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215106-001	CGT	2022-04-20	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215106-002	CGT	2022-04-19	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: dexamethasone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXAMETHASONE	6 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
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
4c619d48-8cf9-4085-8405-c8f066bce19c	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
68788-8293-1	dexamethasone	100 in 1 BOTTLE	TABLET	100		5
68788-8293-5	dexamethasone	15 in 1 BOTTLE	TABLET	15		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8293-1	EA - Each	68788-8293	06ee4fac-680a-48be-9516-dd0c7e45c0b1	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8293	DEXAMETHASONE TABLET [PREFERRED PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 2 package rows	20250316_4c619d48-8cf9-4085-8405-c8f066bce19c.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	Cardinal Health 107, LLC	5622f8d2-1893-441b-8011-fa90c8a63b0b	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215106 application number: ANDA215106
dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	4c619d48-8cf9-4085-8405-c8f066bce19c	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215106 application number: ANDA215106 ndc (product): 68788-8293
dexamethasone	DEXAMETHASONE	Major Pharmaceuticals	64b46398-9b97-45e8-b1ba-1a202d574448	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215106 application number: ANDA215106
dexamethasone	DEXAMETHASONE	Amneal Pharmaceuticals NY LLC	ac71f888-c83a-46a5-921c-1ebdf6cfadc1	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215106 application number: ANDA215106

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
197583	dexAMETHasone 6 MG Oral Tablet	PSN	4c619d48-8cf9-4085-8405-c8f066bce19c	5
197583	dexamethasone 6 MG Oral Tablet	SCD	4c619d48-8cf9-4085-8405-c8f066bce19c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8293-1	68788829301	100 TABLET in 1 BOTTLE (68788-8293-1)	100 tablet	2022-11-29	0000-00-00	No	No	Current
68788-8293-5	68788829305	15 TABLET in 1 BOTTLE (68788-8293-5)	15 tablet	2023-05-03		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Tablets, USP (4 mg and 6 mg) Rx Only	Preferred Pharmaceuticals Inc.	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	5