Dexamethasone

Product NDC
70518-2998
11-digit product format
705182998
Labeler code
70518
Product ID
70518-2998_b9f7af92-373e-6ba6-e053-2995a90af0c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA088316
Marketing category
ANDA
Marketing start
2021-01-25
Marketing end
0000-00-00
Substance
DEXAMETHASONE
Active strength
6 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct70518-2998DDiscontinued by firm2026-08-03
excluded packagepackage70518-299870518-2998-0DDiscontinued by firm2026-08-03

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 · 24 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 packagepackage70518-2998-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2998-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2998-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2998-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2998-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2998-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2998-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2998-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2998-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2998-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2998-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2998-0557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088316-001DEXAMETHASONE6MGTABLET / ORALBPRS1983-09-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088316-001DEXAMETHASONE6MGTABLET / ORALABRS1983-09-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088316-001DEXAMETHASONE6MGTABLET / ORALBPRS1983-09-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A088316-001DEXAMETHASONE6MGTABLET / ORALBPRS1983-09-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088316-001DEXAMETHASONE6MGTABLET / ORALBPRS1983-09-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088316-001DEXAMETHASONE6MGTABLET / ORALBPRS1983-09-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088316-001DEXAMETHASONE6MGTABLET / ORALBPRS1983-09-153f01610625f2…
2019-09-15 20:21 UTC2019-09A088316-001DEXAMETHASONE6MGTABLET / ORALBPRS1983-09-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A088316-001DEXAMETHASONE6MGTABLET / ORALBPRS1983-09-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088316-001DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088316-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088316-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088316-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088316-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088316-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088316-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088316-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088316-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088316-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088316-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088316-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088316-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088316-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088316-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088316-001BP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088316-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088316-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088316-001BP187673890dc5c…
2021-03-12 10:30 UTC2021-03A088316-001BP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088316-001BP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088316-001BP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088316-001BP13f01610625f2…
2019-09-15 20:21 UTC2019-09A088316-001BP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088316-001BP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088316-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088316-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088316-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088316-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088316-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088316-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088316-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088316-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088316-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088316-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088316-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088316-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088316-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2998-0EA - Each70518-2998447b277a-ee9f-4fef-ad03-5602dc023db412024-04-05

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONEBryant Ranch Prepacka9fd2013-0797-4ec4-82c5-07d2825226252020-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088316
application number: ANDA088316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2998-07051829980030 TABLET in 1 BLISTER PACK (70518-2998-0) 30 tablet2021-01-250000-00-00NoNoCurrent