Dxevo

Product NDC: 70569-151
11-digit product format: 705690151
Labeler code: 70569
Product ID: 70569-151_9756260b-1739-ae5d-e053-2995a90a13fd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Phlight Pharma, LLC
Application: ANDA201270
Marketing category: ANDA
Marketing start: 2019-06-17
Marketing end: 0000-00-00
Substance: DEXAMETHASONE
Active strength: 2 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70569-151		D	Discontinued by firm		2026-08-03
excluded package	package	70569-151	70569-151-11	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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70569-151-11	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70569-151-11	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70569-151-11	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70569-151-11	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70569-151-11	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70569-151-11	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70569-151-11	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70569-151-11	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70569-151-11	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70569-151-11	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70569-151-11	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70569-151-11	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70569-151-11	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70569-151-11	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70569-151-11	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	70569-151-11	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

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
A201270-001	DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB		2017-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201270-001	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.

Product history page 1 of 2 · 41 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	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A201270-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201270-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201270-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201270-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201270-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201270-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201270-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201270-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201270-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201270-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201270-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201270-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201270-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201270-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201270-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201270-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201270-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201270-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201270-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201270-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201270-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201270-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201270-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201270-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201270-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201270-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201270-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201270-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201270-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201270-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201270-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201270-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201270-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201270-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201270-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201270-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201270-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201270-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201270-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201270-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70569-151-11	2023-07-23	C162847	48780-1	ba0f9c33-3e8b-a910-e053-dadaa90a0b85	Dxevo (Dexamethasone Tablets USP), 1.5 mg Rx Only
70569-151-11	2021-01-29	C162847	48780-1	ba0f9c33-3e8b-a910-e053-dadaa90a0b85	Dxevo (Dexamethasone Tablets USP), 1.5 mg Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70569-151-11	EA - Each	70569-151	7c645ca2-7ab1-4fb9-9f73-61516635353b	1	2019-06-19

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	01cfaa3e-5e30-18fa-e063-6394a90a084e	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201270 application number: ANDA201270
Dexamethasone 1.5 mg	DEXAMETHASONE 1.5 MG	Larken Laboratories, Inc.	7b997c26-e6a3-403c-93fb-b1290cf5dbad	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201270 application number: ANDA201270
Dexamethasone 1.5 mg	DEXAMETHASONE 1.5 MG	Larken Laboratories, Inc.	fcc75691-974e-4a67-b9d7-64dde72b5595	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201270 application number: ANDA201270
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	45fd8030-dbe3-4da4-9d0a-6549cf4f7359	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201270 application number: ANDA201270
Dexamethasone 1.5 mg	DEXAMETHASONE 1.5 MG	Proficient Rx LP	42db0356-3948-444c-bda3-1226b4ca8985	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201270 application number: ANDA201270

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dxevo (Dexamethasone Tablets USP), 1.5 mg Rx Only	Phlight Pharma, LLC	2019-11-14	HUMAN PRESCRIPTION DRUG LABEL	3