DEXAMETHASONE

Product NDC
72888-238
11-digit product format
728880238
Labeler code
72888
Product ID
72888-238_99311cd0-f11e-4313-bb8c-eeb09fdcb3f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXAMETHASONE
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Ltd.
Application
ANDA218372
Marketing category
ANDA
Marketing start
2025-10-15
Substance
DEXAMETHASONE
Active strength
1.5 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 43.

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
A218372-001DEXAMETHASONEDEXAMETHASONE0.5MGTABLET / ORALAB2024-09-17
A218372-002DEXAMETHASONEDEXAMETHASONE0.75MGTABLET / ORALAB2024-09-17
A218372-003DEXAMETHASONEDEXAMETHASONE1MGTABLET / ORALAB2024-09-17
A218372-004DEXAMETHASONEDEXAMETHASONE1.5MGTABLET / ORALAB2024-09-17
A218372-005DEXAMETHASONEDEXAMETHASONE2MGTABLET / ORALAB2024-09-17
A218372-006DEXAMETHASONEDEXAMETHASONE4MGTABLET / ORALAB2024-09-17
A218372-007DEXAMETHASONEDEXAMETHASONE6MGTABLET / ORALAB2024-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218372-001AB
A218372-002AB
A218372-003AB
A218372-004AB
A218372-005AB
A218372-006AB
A218372-007AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218372-001DEXAMETHASONE0.5MGTABLET / ORALAB2024-09-1784e616aacf4f…
2026-09-14 22:38:342026-08A218372-002DEXAMETHASONE0.75MGTABLET / ORALAB2024-09-1784e616aacf4f…
2026-09-14 22:38:342026-08A218372-003DEXAMETHASONE1MGTABLET / ORALAB2024-09-1784e616aacf4f…
2026-09-14 22:38:342026-08A218372-004DEXAMETHASONE1.5MGTABLET / ORALAB2024-09-1784e616aacf4f…
2026-09-14 22:38:342026-08A218372-005DEXAMETHASONE2MGTABLET / ORALAB2024-09-1784e616aacf4f…
2026-09-14 22:38:342026-08A218372-006DEXAMETHASONE4MGTABLET / ORALAB2024-09-1784e616aacf4f…
2026-09-14 22:38:342026-08A218372-007DEXAMETHASONE6MGTABLET / ORALAB2024-09-1784e616aacf4f…
2026-08-18 06:07:402026-07A218372-001DEXAMETHASONE0.5MGTABLET / ORALAB2024-09-17caaa826d4ba7…
2026-08-18 06:07:402026-07A218372-002DEXAMETHASONE0.75MGTABLET / ORALAB2024-09-17caaa826d4ba7…
2026-08-18 06:07:402026-07A218372-003DEXAMETHASONE1MGTABLET / ORALAB2024-09-17caaa826d4ba7…
2026-08-18 06:07:402026-07A218372-004DEXAMETHASONE1.5MGTABLET / ORALAB2024-09-17caaa826d4ba7…
2026-08-18 06:07:402026-07A218372-005DEXAMETHASONE2MGTABLET / ORALAB2024-09-17caaa826d4ba7…
2026-08-18 06:07:402026-07A218372-006DEXAMETHASONE4MGTABLET / ORALAB2024-09-17caaa826d4ba7…
2026-08-18 06:07:402026-07A218372-007DEXAMETHASONE6MGTABLET / ORALAB2024-09-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218372-001DEXAMETHASONE0.5MGTABLET / ORALAB2024-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218372-002DEXAMETHASONE0.75MGTABLET / ORALAB2024-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218372-003DEXAMETHASONE1MGTABLET / ORALAB2024-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218372-004DEXAMETHASONE1.5MGTABLET / ORALAB2024-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218372-005DEXAMETHASONE2MGTABLET / ORALAB2024-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218372-006DEXAMETHASONE4MGTABLET / ORALAB2024-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218372-007DEXAMETHASONE6MGTABLET / ORALAB2024-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-001DEXAMETHASONE0.5MGTABLET / ORALAB2024-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-002DEXAMETHASONE0.75MGTABLET / ORALAB2024-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-003DEXAMETHASONE1MGTABLET / ORALAB2024-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-004DEXAMETHASONE1.5MGTABLET / ORALAB2024-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-005DEXAMETHASONE2MGTABLET / ORALAB2024-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-006DEXAMETHASONE4MGTABLET / ORALAB2024-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-007DEXAMETHASONE6MGTABLET / ORALAB2024-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A218372-001DEXAMETHASONE0.5MGTABLET / ORALAB2024-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218372-002DEXAMETHASONE0.75MGTABLET / ORALAB2024-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218372-003DEXAMETHASONE1MGTABLET / ORALAB2024-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218372-004DEXAMETHASONE1.5MGTABLET / ORALAB2024-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218372-005DEXAMETHASONE2MGTABLET / ORALAB2024-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218372-006DEXAMETHASONE4MGTABLET / ORALAB2024-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218372-007DEXAMETHASONE6MGTABLET / ORALAB2024-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218372-001DEXAMETHASONE0.5MGTABLET / ORALAB2024-09-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218372-002DEXAMETHASONE0.75MGTABLET / ORALAB2024-09-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218372-003DEXAMETHASONE1MGTABLET / ORALAB2024-09-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218372-004DEXAMETHASONE1.5MGTABLET / ORALAB2024-09-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218372-005DEXAMETHASONE2MGTABLET / ORALAB2024-09-17fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218372-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A218372-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A218372-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A218372-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A218372-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A218372-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A218372-007AB184e616aacf4f…
2026-08-18 06:07:402026-07A218372-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218372-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218372-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218372-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218372-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218372-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218372-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218372-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218372-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218372-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218372-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218372-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218372-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218372-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218372-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218372-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218372-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218372-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218372-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218372-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218372-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218372-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218372-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218372-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218372-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218372-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218372-005AB1fd3edfee7708…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE1.5 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 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197577Internal RxNorm lookup
197579Internal RxNorm lookup
197580Internal RxNorm lookup
197581Internal RxNorm lookup
197582Internal RxNorm lookup
197583Internal RxNorm lookup
343033Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c1729db-8ba3-4cba-9eff-ab4ae2c061c2Available 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
72888-238-01DEXAMETHASONE100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-238-01EA - Each72888-238aa8575ff-f34a-4935-80e1-38588a5d727712025-11-13

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXAMETHASONEDEXAMETHASONENuCare Pharmaceuticals, Inc.4a808dd5-35b7-e879-e063-6394a90a0bf72026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218372
application number: ANDA218372
DEXAMETHASONEDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.a8d6792e-757e-4dc6-adf5-0d92110754282025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218372
application number: ANDA218372
DEXAMETHASONEDEXAMETHASONEAdvagen Pharma Ltd.3c1729db-8ba3-4cba-9eff-ab4ae2c061c22025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218372
application number: ANDA218372
ndc (product): 72888-238

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197577dexAMETHasone 0.5 MG Oral TabletPSN3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
343033dexAMETHasone 0.75 MG Oral TabletPSN3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
197579dexAMETHasone 1 MG Oral TabletPSN3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
197580dexAMETHasone 1.5 MG Oral TabletPSN3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
197581dexAMETHasone 2 MG Oral TabletPSN3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
197582dexAMETHasone 4 MG Oral TabletPSN3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
197583dexAMETHasone 6 MG Oral TabletPSN3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
197577dexamethasone 0.5 MG Oral TabletSCD3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
343033dexamethasone 0.75 MG Oral TabletSCD3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
197579dexamethasone 1 MG Oral TabletSCD3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
197580dexamethasone 1.5 MG Oral TabletSCD3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
197581dexamethasone 2 MG Oral TabletSCD3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
197582dexamethasone 4 MG Oral TabletSCD3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
197583dexamethasone 6 MG Oral TabletSCD3c1729db-8ba3-4cba-9eff-ab4ae2c061c22
197580dexAMETHasone 1.5 MG Oral TabletPSN4a808dd5-35b7-e879-e063-6394a90a0bf71
197580dexamethasone 1.5 MG Oral TabletSCD4a808dd5-35b7-e879-e063-6394a90a0bf71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-238-0172888023801100 TABLET in 1 BOTTLE (72888-238-01) 100 tablet2025-10-15NoNoCurrent