Dexamethasone

Product NDC
63187-561
11-digit product format
631870561
Labeler code
63187
Product ID
63187-561_64c0e623-ed7a-4168-83e4-8cd3905d06aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA084612
Marketing category
ANDA
Marketing start
1978-07-19
Substance
DEXAMETHASONE
Active strength
4 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084612-001DEXAMETHASONEDEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 1982
A084612-002DEXAMETHASONEDEXAMETHASONE0.5MGTABLET / ORALABRLD, Approved before 1982
A084612-003DEXAMETHASONEDEXAMETHASONE0.75MGTABLET / ORALABRLD, Approved before 1982
A084612-004DEXAMETHASONEDEXAMETHASONE1MGTABLET / ORALABRLD, RS1983-09-15
A084612-005DEXAMETHASONEDEXAMETHASONE1.5MGTABLET / ORALABRLD, Approved before 1982
A084612-006DEXAMETHASONEDEXAMETHASONE2MGTABLET / ORALABRLD, RS, Approved before 1982
A084612-007DEXAMETHASONEDEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A084612-001AB
A084612-002AB
A084612-003AB
A084612-004AB
A084612-005AB
A084612-006AB
A084612-007AB

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 · 65 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084612-002DEXAMETHASONE0.5MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084612-003DEXAMETHASONE0.75MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084612-004DEXAMETHASONE1MGTABLET / ORALABRLD, RS1983-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084612-005DEXAMETHASONE1.5MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084612-006DEXAMETHASONE2MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084612-007DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-002DEXAMETHASONE0.5MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-003DEXAMETHASONE0.75MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-004DEXAMETHASONE1MGTABLET / ORALABRLD, RS1983-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-005DEXAMETHASONE1.5MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-006DEXAMETHASONE2MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-007DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084612-002DEXAMETHASONE0.5MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084612-003DEXAMETHASONE0.75MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084612-004DEXAMETHASONE1MGTABLET / ORALABRLD, RS1983-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084612-005DEXAMETHASONE1.5MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084612-006DEXAMETHASONE2MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084612-007DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084612-001DEXAMETHASONE4MGTABLET / ORALBPApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084612-001DEXAMETHASONE4MGTABLET / ORALABApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084612-001DEXAMETHASONE4MGTABLET / ORALBPApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A084612-001DEXAMETHASONE4MGTABLET / ORALBPApproved before 19825aa47cf7b7d7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 65 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A084612-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084612-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084612-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084612-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084612-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084612-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084612-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084612-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A084612-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084612-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084612-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084612-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084612-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084612-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084612-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084612-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084612-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084612-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084612-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084612-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084612-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084612-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084612-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084612-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084612-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084612-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084612-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084612-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084612-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084612-001BP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084612-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084612-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084612-001BP187673890dc5c…
2021-03-12 10:30 UTC2021-03A084612-001BP15aa47cf7b7d7…

Additional Listing Data#

Finished product
Yes
Brand name base
Dexamethasone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE4 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
99296e80-3ca6-4430-9ef7-adca357c31b3Available 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
63187-561-00Dexamethasone100 in 1 BOTTLE, PLASTICTABLET1007
63187-561-10Dexamethasone10 in 1 BOTTLE, PLASTICTABLET107
63187-561-15Dexamethasone15 in 1 BOTTLE, PLASTICTABLET157
63187-561-24Dexamethasone24 in 1 BOTTLE, PLASTICTABLET247
63187-561-30Dexamethasone30 in 1 BOTTLE, PLASTICTABLET307
63187-561-60Dexamethasone60 in 1 BOTTLE, PLASTICTABLET607
63187-561-90Dexamethasone90 in 1 BOTTLE, PLASTICTABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-561-10EA - Each63187-561f4a9da41-27af-485e-9a39-5e67881c81ef12016-11-08
63187-561-15EA - Each63187-56182bf3a80-a89d-47a5-a1ee-28b5a3f5b15b12019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLDEXAMETHASONE TABLET [PROFICIENT RX LP]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE TABLET [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDEXAMETHASONE TABLET [PROFICIENT RX LP]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDEXAMETHASONE TABLET [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DEXAMETHASONE TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDEXAMETHASONE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEXAMETHASONE TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEXAMETHASONE TABLET [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554DEXAMETHASONE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-561DEXAMETHASONE TABLET [PROFICIENT RX LP]7Current NDC, Legacy NDC, 7 package rows20220622_99296e80-3ca6-4430-9ef7-adca357c31b3.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.f5c9b70b-b835-4f3b-9643-0aec50a0d3f22026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.89e1d458-7caa-430f-9c54-360889899a732026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
DexamethasoneDEXAMETHASONECardinal Health 107, LLCbf8acfdb-8dc8-4a69-90b0-33c680c421d62026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
DexamethasoneDEXAMETHASONENorthwind Health Company, LLCaa30086a-8551-413e-9cf2-6393093cfcfd2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
DexamethasoneDEXAMETHASONEGolden State Medical Supply, Inc.a7455c92-41ce-4e87-e053-2995a90a610f2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
Dexamethasone IntensolDEXAMETHASONE INTENSOLHikma Pharmaceuticals USA, Inc.b15200fb-1826-472b-a907-e677a272513b2025-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
DEXAMETHASONEDEXAMETHASONEDirect Rxcc7140de-a205-f675-e053-2995a90ac22b2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
DexamethasoneDEXAMETHASONEProficient Rx LP99296e80-3ca6-4430-9ef7-adca357c31b32022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
ndc (product): 63187-561
DexamethasoneDEXAMETHASONEDoc Rxf1c30431-554b-4161-9d8c-5795c689e0bd2021-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
DexamethasoneDEXAMETHASONEBryant Ranch Prepack89e570c9-3e64-433b-9779-b94332f2b5ef2020-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197582dexAMETHasone 4 MG Oral TabletPSN99296e80-3ca6-4430-9ef7-adca357c31b37
197582dexamethasone 4 MG Oral TabletSCD99296e80-3ca6-4430-9ef7-adca357c31b37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-561-0063187056100100 TABLET in 1 BOTTLE, PLASTIC (63187-561-00) 100 tablet2015-10-010000-00-00NoNoCurrent
63187-561-106318705611010 TABLET in 1 BOTTLE, PLASTIC (63187-561-10) 10 tablet2016-10-030000-00-00NoNoCurrent
63187-561-156318705611515 TABLET in 1 BOTTLE, PLASTIC (63187-561-15) 15 tablet2019-09-010000-00-00NoNoCurrent
63187-561-246318705612424 TABLET in 1 BOTTLE, PLASTIC (63187-561-24) 24 tablet2015-10-010000-00-00NoNoCurrent
63187-561-306318705613030 TABLET in 1 BOTTLE, PLASTIC (63187-561-30) 30 tablet2015-10-010000-00-00NoNoCurrent
63187-561-606318705616060 TABLET in 1 BOTTLE, PLASTIC (63187-561-60) 60 tablet2015-10-010000-00-00NoNoCurrent
63187-561-906318705619090 TABLET in 1 BOTTLE, PLASTIC (63187-561-90) 90 tablet2015-10-010000-00-00NoNoCurrent