Dexamethasone

Product NDC
55154-4914
11-digit product format
551544914
Labeler code
55154
Product ID
55154-4914_2851f8b5-3a10-44ea-90f4-2a2b8f3b3ae9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA087916
Marketing category
ANDA
Marketing start
1982-08-26
Substance
DEXAMETHASONE
Active strength
2 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

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 ZIP2025-03A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087916-001DEXAMETHASONE2MGTABLET / ORALBPRLD, RS1982-08-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087916-001DEXAMETHASONE2MGTABLET / ORALBPRLD, RS1982-08-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087916-001DEXAMETHASONE2MGTABLET / ORALBPRLD, RS1982-08-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087916-001DEXAMETHASONE2MGTABLET / ORALBP1982-08-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087916-001DEXAMETHASONE2MGTABLET / ORALBPRLD, RS1982-08-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087916-001DEXAMETHASONE2MGTABLET / ORALBPRLD, RS1982-08-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087916-001DEXAMETHASONE2MGTABLET / ORALBP1982-08-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A087916-001DEXAMETHASONE2MGTABLET / ORALBP1982-08-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087916-001DEXAMETHASONE2MGTABLET / ORALBP1982-08-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087916-001DEXAMETHASONE2MGTABLET / ORALBP1982-08-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087916-001DEXAMETHASONE2MGTABLET / ORALBP1982-08-263f01610625f2…
2019-09-15 20:21 UTC2019-09A087916-001DEXAMETHASONE2MGTABLET / ORALBP1982-08-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A087916-001DEXAMETHASONE2MGTABLET / ORALBP1982-08-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087916-001DEXAMETHASONE2MGTABLET / ORALABRLD, RS1982-08-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087916-001DEXAMETHASONE2MGTABLET / ORALBPRLD, RS1982-08-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087916-001DEXAMETHASONE2MGTABLET / ORALBPRLD, RS1982-08-26cb3db0bc1861…

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 ZIP2025-03A087916-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087916-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087916-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087916-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087916-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087916-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087916-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087916-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087916-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087916-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087916-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087916-001BP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087916-001BP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087916-001BP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087916-001BP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087916-001BP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087916-001BP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087916-001BP187673890dc5c…
2021-03-12 10:30 UTC2021-03A087916-001BP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087916-001BP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087916-001BP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087916-001BP13f01610625f2…
2019-09-15 20:21 UTC2019-09A087916-001BP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087916-001BP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087916-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087916-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087916-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087916-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087916-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087916-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087916-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087916-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087916-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087916-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087916-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087916-001BP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087916-001BP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7S5I7G3JQLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197581Internal RxNorm lookup
197582Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bf8acfdb-8dc8-4a69-90b0-33c680c421d6Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4914-0Dexamethasone1 in 1 BLISTER PACKTABLET115
55154-4914-0Dexamethasone10 in 1 BAGTABLET1015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLDEXAMETHASONE TABLET [CARDINAL HEALTH]2
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE TABLET [CARDINAL HEALTH]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDEXAMETHASONE TABLET [CARDINAL HEALTH]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDEXAMETHASONE TABLET [CARDINAL HEALTH]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DEXAMETHASONE TABLET [CARDINAL HEALTH]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDEXAMETHASONE TABLET [CARDINAL HEALTH]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEXAMETHASONE TABLET [CARDINAL HEALTH]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEXAMETHASONE TABLET [CARDINAL HEALTH]2
sucroseINACTIVE INGREDIENTC151H8M554DEXAMETHASONE TABLET [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4914DEXAMETHASONE TABLET [CARDINAL HEALTH 107, LLC]13Current NDC, Legacy NDC, 2 package rows20240726_bf8acfdb-8dc8-4a69-90b0-33c680c421d6.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONECardinal Health 107, LLCbf8acfdb-8dc8-4a69-90b0-33c680c421d62026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087916
application number: ANDA087916
ndc (product): 55154-4914
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.2ceb3a01-f5bb-4538-b5c1-cea400901d022025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087916
application number: ANDA087916
DexamethasoneDEXAMETHASONEDoc Rxf1c30431-554b-4161-9d8c-5795c689e0bd2021-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087916
application number: ANDA087916
DexamethasoneDEXAMETHASONEProficient Rx LP35307d74-aed8-4c6b-9568-2223a4f350bd2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087916
application number: ANDA087916

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197581dexAMETHasone 2 MG Oral TabletPSNbf8acfdb-8dc8-4a69-90b0-33c680c421d615
197582dexAMETHasone 4 MG Oral TabletPSNbf8acfdb-8dc8-4a69-90b0-33c680c421d615
197581dexamethasone 2 MG Oral TabletSCDbf8acfdb-8dc8-4a69-90b0-33c680c421d615
197582dexamethasone 4 MG Oral TabletSCDbf8acfdb-8dc8-4a69-90b0-33c680c421d615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4914-05515449140010 BLISTER PACK in 1 BAG (55154-4914-0) / 1 TABLET in 1 BLISTER PACK10 blister pack1982-08-260000-00-00NoNoCurrent