Dexamethasone

Product NDC
51655-012
Requested package NDC
51655-012-87
11-digit product format
516550012
Labeler code
51655
Product ID
51655-012_46dda880-497d-fa44-e063-6394a90ad5f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA084612
Marketing category
ANDA
Marketing start
2014-08-11
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

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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

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
aa30086a-8551-413e-9cf2-6393093cfcfdAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-012-03Dexamethasone3 in 1 BOTTLE, DISPENSINGTABLET35
51655-012-87Dexamethasone6 in 1 BOTTLE, DISPENSINGTABLET65

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLDEXAMETHSONE (DEXAMETHASONE) TABLET [NORTHWIND PHARMACEUTICALS, LLC]2
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHSONE (DEXAMETHASONE) TABLET [NORTHWIND PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-012DEXAMETHASONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240724_aa30086a-8551-413e-9cf2-6393093cfcfd.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
ndc (package): 51655-012-87
ndc (product): 51655-012
ndc11 (package): 51655001287
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
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 TabletPSNaa30086a-8551-413e-9cf2-6393093cfcfd5
197582dexamethasone 4 MG Oral TabletSCDaa30086a-8551-413e-9cf2-6393093cfcfd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-012-87516550012876 TABLET in 1 BOTTLE, DISPENSING (51655-012-87) 6 tablet2014-08-11NoNoCurrent