TaperDex 6-day

Product NDC: 42195-121
Requested package NDC: 42195-121-06
11-digit product format: 421950121
Labeler code: 42195
Product ID: 42195-121_c5bbddef-1a48-445d-bd74-da00fc4ca4a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXAMETHASONE
Dosage form: TABLET
Route: ORAL
Labeler: Xspire Pharma, Llc
Application: ANDA088237
Marketing category: ANDA
Marketing start: 2018-01-19
Marketing end: 0000-00-00
Substance: DEXAMETHASONE
Active strength: 2 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42195-121	42195-121-06	I	Inactivated by FDA		2026-08-11

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A088237-001	DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET / ORAL			1983-04-28

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	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A088237-001	BP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088237-001	BP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088237-001	BP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088237-001	BP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088237-001	BP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088237-001	BP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088237-001	BP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088237-001	BP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088237-001	BP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088237-001	BP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088237-001	BP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088237-001	BP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088237-001	BP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088237-001	BP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088237-001	BP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088237-001	BP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088237-001	BP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088237-001	BP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088237-001	BP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088237-001	BP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088237-001	BP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088237-001	BP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088237-001	BP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088237-001	BP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088237-001	BP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088237-001	BP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088237-001	BP	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42195-121-06	2024-01-30	C162847	48780-1	1030e365-4407-111a-e063-dadaa90a10e2	TaperDex TM 6-day Therapy Pack DEXAMETHASONE TABLETS USP, 1.5 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42195-121-06	TaperDex 6-day	21 in 1 BLISTER PACK	TABLET	21		5
42195-121-06	TaperDex 6-day	1 in 1 CARTON	TABLET	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42195-121-06	EA - Each	42195-121	07b3f27b-82b6-4806-aaf0-8e32900b744e	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42195-121	TAPERDEX 6-DAY (DEXAMETHASONE) TABLET [XSPIRE PHARMA, LLC]	5	Legacy NDC, 2 package rows	20220119_1f5481d3-1ba0-44b1-8008-6c7c1137049a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TaperDex 6-day	DEXAMETHASONE	Proficient Rx LP	a0d298f3-6ba6-45a5-81bf-82a3ad93d0a9	2020-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088237 application number: ANDA088237
TaperDex 12-day	DEXAMETHASONE	Proficient Rx LP	d66e36d3-f6f8-4fa8-84fb-7717463e37b3	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088237 application number: ANDA088237

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
1998482	{21 (dexamethasone 1.5 MG Oral Tablet) } Pack [TaperDex 6 Day Taper]	BPCK	1f5481d3-1ba0-44b1-8008-6c7c1137049a	5
846192	{21 (dexamethasone 1.5 MG Oral Tablet) } Pack	GPCK	1f5481d3-1ba0-44b1-8008-6c7c1137049a	5
197580	dexAMETHasone 1.5 MG Oral Tablet	PSN	1f5481d3-1ba0-44b1-8008-6c7c1137049a	5
846192	dexAMETHasone 1.5 MG Tablet 6 Day 21 Count Pack	PSN	1f5481d3-1ba0-44b1-8008-6c7c1137049a	5
1998482	TaperDex 1.5 MG Tablet 6 Day 21 Count Pack	PSN	1f5481d3-1ba0-44b1-8008-6c7c1137049a	5
197580	dexamethasone 1.5 MG Oral Tablet	SCD	1f5481d3-1ba0-44b1-8008-6c7c1137049a	5
1998482	TaperDex 6 Day Taper Pack	SY	1f5481d3-1ba0-44b1-8008-6c7c1137049a	5
1998482	{21 (dexamethasone 1.5 MG Oral Tablet) } Pack [TaperDex 6 Day Taper]	BPCK	a0d298f3-6ba6-45a5-81bf-82a3ad93d0a9	4
846192	{21 (dexamethasone 1.5 MG Oral Tablet) } Pack	GPCK	a0d298f3-6ba6-45a5-81bf-82a3ad93d0a9	4
197580	dexAMETHasone 1.5 MG Oral Tablet	PSN	a0d298f3-6ba6-45a5-81bf-82a3ad93d0a9	4
846192	dexAMETHasone 1.5 MG Tablet 6 Day 21 Count Pack	PSN	a0d298f3-6ba6-45a5-81bf-82a3ad93d0a9	4
1998482	TaperDex 1.5 MG Tablet 6 Day 21 Count Pack	PSN	a0d298f3-6ba6-45a5-81bf-82a3ad93d0a9	4
197580	dexamethasone 1.5 MG Oral Tablet	SCD	a0d298f3-6ba6-45a5-81bf-82a3ad93d0a9	4
1998482	TaperDex 6 Day Taper Pack	SY	a0d298f3-6ba6-45a5-81bf-82a3ad93d0a9	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42195-121-06	42195012106	1 BLISTER PACK in 1 CARTON (42195-121-06) > 21 TABLET in 1 BLISTER PACK	1 blister pack	2018-01-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TaperDex TM 6-day Therapy Pack DEXAMETHASONE TABLETS USP, 1.5 mg Rx Only	Xspire Pharma, Llc \| XSPIRE PHARMA	2022-01-18	HUMAN PRESCRIPTION DRUG LABEL	5
TaperDex TM 6-day Therapy Pack DEXAMETHASONE TABLETS USP, 1.5 mg Rx Only	Quality Care Products, LLC	2020-03-31	HUMAN PRESCRIPTION DRUG LABEL	1
TaperDex 6-day DEXAMETHASONE TABLETS USP, 1.5 mg Rx Only	Proficient Rx LP	2020-03-01	HUMAN PRESCRIPTION DRUG LABEL	4