TaperDex 6-day

Product NDC
42195-121
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42195-121IInactivated by FDA2026-08-10
excluded packagepackage42195-12142195-121-06IInactivated by FDA2026-08-10

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42195-121-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42195-121-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42195-121-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42195-121-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42195-121-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42195-121-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42195-121-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42195-121-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42195-121-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42195-121-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42195-121-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42195-121-06557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42195-121-068af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42195-121-06834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42195-121-061332a3947898…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088237-001DEXAMETHASONEDEXAMETHASONE1.5MGTABLET / ORAL1983-04-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088237-001DEXAMETHASONE1.5MGTABLET / ORAL1983-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-283f01610625f2…
2019-09-15 20:21 UTC2019-09A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088237-001DEXAMETHASONE1.5MGTABLET / ORALBP1983-04-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A088237-001BP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088237-001BP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088237-001BP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088237-001BP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088237-001BP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088237-001BP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088237-001BP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088237-001BP187673890dc5c…
2021-03-12 10:30 UTC2021-03A088237-001BP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088237-001BP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088237-001BP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088237-001BP13f01610625f2…
2019-09-15 20:21 UTC2019-09A088237-001BP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088237-001BP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088237-001BP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088237-001BP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088237-001BP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088237-001BP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088237-001BP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088237-001BP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088237-001BP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088237-001BP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088237-001BP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088237-001BP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088237-001BP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088237-001BP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088237-001BP1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42195-121-062024-01-30C16284748780-11030e365-4407-111a-e063-dadaa90a10e2TaperDex TM 6-day Therapy Pack DEXAMETHASONE TABLETS USP, 1.5 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42195-121-06TaperDex 6-day21 in 1 BLISTER PACKTABLET215
42195-121-06TaperDex 6-day1 in 1 CARTONTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42195-121-06EA - Each42195-12107b3f27b-82b6-4806-aaf0-8e32900b744e12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42195-121TAPERDEX 6-DAY (DEXAMETHASONE) TABLET [XSPIRE PHARMA, LLC]5Legacy NDC, 2 package rows20220119_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TaperDex 6-dayDEXAMETHASONEProficient Rx LPa0d298f3-6ba6-45a5-81bf-82a3ad93d0a92020-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088237
application number: ANDA088237
TaperDex 12-dayDEXAMETHASONEProficient Rx LPd66e36d3-f6f8-4fa8-84fb-7717463e37b32019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088237
application number: ANDA088237

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1998482{21 (dexamethasone 1.5 MG Oral Tablet) } Pack [TaperDex 6 Day Taper]BPCK1f5481d3-1ba0-44b1-8008-6c7c1137049a5
846192{21 (dexamethasone 1.5 MG Oral Tablet) } PackGPCK1f5481d3-1ba0-44b1-8008-6c7c1137049a5
197580dexAMETHasone 1.5 MG Oral TabletPSN1f5481d3-1ba0-44b1-8008-6c7c1137049a5
846192dexAMETHasone 1.5 MG Tablet 6 Day 21 Count PackPSN1f5481d3-1ba0-44b1-8008-6c7c1137049a5
1998482TaperDex 1.5 MG Tablet 6 Day 21 Count PackPSN1f5481d3-1ba0-44b1-8008-6c7c1137049a5
197580dexamethasone 1.5 MG Oral TabletSCD1f5481d3-1ba0-44b1-8008-6c7c1137049a5
1998482TaperDex 6 Day Taper PackSY1f5481d3-1ba0-44b1-8008-6c7c1137049a5
1998482{21 (dexamethasone 1.5 MG Oral Tablet) } Pack [TaperDex 6 Day Taper]BPCKa0d298f3-6ba6-45a5-81bf-82a3ad93d0a94
846192{21 (dexamethasone 1.5 MG Oral Tablet) } PackGPCKa0d298f3-6ba6-45a5-81bf-82a3ad93d0a94
197580dexAMETHasone 1.5 MG Oral TabletPSNa0d298f3-6ba6-45a5-81bf-82a3ad93d0a94
846192dexAMETHasone 1.5 MG Tablet 6 Day 21 Count PackPSNa0d298f3-6ba6-45a5-81bf-82a3ad93d0a94
1998482TaperDex 1.5 MG Tablet 6 Day 21 Count PackPSNa0d298f3-6ba6-45a5-81bf-82a3ad93d0a94
197580dexamethasone 1.5 MG Oral TabletSCDa0d298f3-6ba6-45a5-81bf-82a3ad93d0a94
1998482TaperDex 6 Day Taper PackSYa0d298f3-6ba6-45a5-81bf-82a3ad93d0a94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42195-121-06421950121061 BLISTER PACK in 1 CARTON (42195-121-06) > 21 TABLET in 1 BLISTER PACK1 blister pack2018-01-190000-00-00NoNoCurrent