Application 084612

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONEDEXAMETHASONETABLET;ORAL4MGNoNo
002DEXAMETHASONEDEXAMETHASONETABLET;ORAL0.5MGYesNo
003DEXAMETHASONEDEXAMETHASONETABLET;ORAL0.75MGYesNo
004DEXAMETHASONEDEXAMETHASONETABLET;ORAL1MGYesYes
005DEXAMETHASONEDEXAMETHASONETABLET;ORAL1.5MGYesNo
006DEXAMETHASONEDEXAMETHASONETABLET;ORAL2MGYesYes
007DEXAMETHASONEDEXAMETHASONETABLET;ORAL6MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A084612-001DEXAMETHASONE4MGTABLET / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A084612-002DEXAMETHASONE0.5MGTABLET / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A084612-003DEXAMETHASONE0.75MGTABLET / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A084612-004DEXAMETHASONE1MGTABLET / ORALABRLD, RS1983-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07A084612-005DEXAMETHASONE1.5MGTABLET / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A084612-006DEXAMETHASONE2MGTABLET / ORALABRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A084612-007DEXAMETHASONE6MGTABLET / ORALABRLD, RS1983-09-15caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A084612-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A084612-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A084612-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A084612-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A084612-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A084612-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A084612-007AB1caaa826d4ba7…
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…

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
ndc (product): 70518-1534
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.89e1d458-7caa-430f-9c54-360889899a732026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
ndc (product): 55289-582
DexamethasoneDEXAMETHASONECardinal Health 107, LLCbf8acfdb-8dc8-4a69-90b0-33c680c421d62026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
ndc (product): 55154-4901
DexamethasoneDEXAMETHASONENorthwind Health Company, LLCaa30086a-8551-413e-9cf2-6393093cfcfd2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
ndc (product): 51655-012
DexamethasoneDEXAMETHASONEGolden State Medical Supply, Inc.a7455c92-41ce-4e87-e053-2995a90a610f2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
ndc (product): 51407-361
Dexamethasone IntensolDEXAMETHASONE INTENSOLHikma Pharmaceuticals USA, Inc.b15200fb-1826-472b-a907-e677a272513b2025-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
ndc (product): 0054-4184
ndc (product): 0054-8175
DEXAMETHASONEDEXAMETHASONEDirect Rxcc7140de-a205-f675-e053-2995a90ac22b2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
ndc (product): 72189-254
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
ndc (product): 69306-114
DexamethasoneDEXAMETHASONEBryant Ranch Prepack89e570c9-3e64-433b-9779-b94332f2b5ef2020-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084612
application number: ANDA084612
ndc (product): 63629-3742

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 67 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4184DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4184DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4184DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4184DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
0054-4184DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8175DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8175DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8175DexamethasoneDexamethasoneWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8175DexamethasoneDexamethasoneHikma Pharmaceuticals USA, Inc.ANDACurrent
21695-382DexamethasoneDexamethasoneRebel Distributors CorpANDACurrent
45865-989DexamethasoneDexamethasonemedsource pharmaceuticalsANDACurrent
49999-059DexamethasoneDexamethasoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-059DexamethasoneDexamethasoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-059DexamethasoneDexamethasoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-059DexamethasoneDexamethasoneLake Erie Medical DBA QuaANDACurrent
50090-0088DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0088DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0088DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0088DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0089DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0089DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0089DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
50090-0089DexamethasoneDexamethasoneA-S Medication SolutionsANDACurrent
51407-361DexamethasoneDexamethasoneGolden State Medical SupplyANDACurrent
51407-361DexamethasoneDexamethasoneGolden State Medical SupplyANDACurrent
51407-361DexamethasoneDexamethasoneGolden State Medical Supply, Inc.ANDACurrent
51655-012DexamethsoneDexamethasoneNorthwind Pharmaceuticals, LLCANDACurrent
53217-374DexamethasoneDexamethasoneAidarex Pharmaceuticals LLCANDACurrent
55154-4901DexamethasoneDexamethasoneCardinal HealthANDACurrent
55154-4901DexamethasoneDexamethasoneCardinal Health 107, LLCANDACurrent
55154-4901DexamethasoneDexamethasoneCardinal HealthANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, InANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-582DexamethasoneDexamethasonePD-Rx Pharmaceuticals, Inc.ANDACurrent
63187-561DexamethasoneDexamethasoneProficient Rx LPANDACurrent
63187-561DexamethasoneDexamethasoneProficient Rx LPANDACurrent
63187-561DexamethasoneDexamethasoneProficient Rx LPANDACurrent
63187-561DexamethasoneDexamethasoneProficient Rx LPANDACurrent
63187-561DexamethasoneDexamethasoneProficient Rx LPANDACurrent
63629-3742DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
63629-3742DexamethasoneDexamethasoneBryant Ranch PrepackANDACurrent
66336-479DexamethasoneDexamethasoneDispensing Solutions, Inc.ANDACurrent
67296-0326DexamethasoneDexamethasoneRedPharm DrugANDACurrent
67296-0326DexamethasoneDexamethasoneRedPharm DrugANDACurrent
67296-0326DexamethasoneDexamethasoneRedPharm DrugANDACurrent
68071-2321DexamethasoneDexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2321DexamethasoneDexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7142DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7142DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7142DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7142DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7142DexamethasoneDexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
69306-114DexamethasoneDexamethasoneDoc RxANDACurrent
69306-114DexamethasoneDexamethasoneDoc RxANDACurrent
69306-114DexamethasoneDexamethasoneDoc RxANDACurrent
70518-1534DexamethasoneDexamethasoneREMEDYREPACK INC.ANDACurrent
70518-1534DexamethasoneDexamethasoneREMEDYREPACK INC.ANDACurrent
70518-1534DexamethasoneDexamethasoneREMEDYREPACK INC.ANDACurrent
70518-1534DexamethasoneDexamethasoneREMEDYREPACK INC.ANDACurrent
72189-254DEXAMETHASONEDEXAMETHASONEDirect RxANDACurrent