Dexamethasone

Product NDC
60687-773
11-digit product format
606870773
Labeler code
60687
Product ID
60687-773_288dc0fb-281f-9be7-e063-6394a90a7188
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA217696
Marketing category
ANDA
Marketing start
2023-12-01
Substance
DEXAMETHASONE
Active strength
2 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217696-001DEXAMETHASONEDEXAMETHASONE2MGTABLET / ORALAB2023-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217696-001AB

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
2026-02-19 14:30 UTC2026-02A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-093f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217696-001DEXAMETHASONE2MGTABLET / ORALAB2023-05-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217696-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217696-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217696-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217696-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217696-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217696-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217696-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217696-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217696-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217696-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217696-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217696-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217696-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217696-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217696-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217696-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217696-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217696-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217696-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217696-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A217696-001AB13f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217696-001AB1a50c72e98297…

Additional Listing Data#

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

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197581Internal RxNorm lookup
197582Internal RxNorm lookup
197583Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
23deb5f1-d357-45af-9851-d1249bdfa6ddAvailable 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
60687-773-01Dexamethasone100 in 1 CARTONTABLET1005
60687-773-11Dexamethasone1 in 1 BLISTER PACKTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-773-01EA - Each60687-7735d730455-b0ca-446c-9a4d-f4361be6feff12023-12-05
60687-773-11EA - Each60687-773e6ed70d8-865a-485f-9263-7175075c736b12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-773DEXAMETHASONE TABLET [AMERICAN HEALTH PACKAGING]5Current NDC, 2 package rows20241210_23deb5f1-d357-45af-9851-d1249bdfa6dd.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
DexamethasoneDEXAMETHASONEDirect_Rx0a0db8e7-8474-3d08-e063-6294a90af3f52026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217696
application number: ANDA217696
DexamethasoneDEXAMETHASONEAmerican Health Packaging23deb5f1-d357-45af-9851-d1249bdfa6dd2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217696
application number: ANDA217696
ndc (product): 60687-773
DexamethasoneDEXAMETHASONENorthStar Rx LLC05c77a4c-c508-babd-e063-6294a90a450a2024-03-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217696
application number: ANDA217696
DexamethasoneDEXAMETHASONEANI Pharmaceuticals, Inc.fe8cf911-84ef-47be-acb8-0501b546299b2024-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217696
application number: ANDA217696

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197581dexAMETHasone 2 MG Oral TabletPSN23deb5f1-d357-45af-9851-d1249bdfa6dd5
197582dexAMETHasone 4 MG Oral TabletPSN23deb5f1-d357-45af-9851-d1249bdfa6dd5
197583dexAMETHasone 6 MG Oral TabletPSN23deb5f1-d357-45af-9851-d1249bdfa6dd5
197581dexamethasone 2 MG Oral TabletSCD23deb5f1-d357-45af-9851-d1249bdfa6dd5
197582dexamethasone 4 MG Oral TabletSCD23deb5f1-d357-45af-9851-d1249bdfa6dd5
197583dexamethasone 6 MG Oral TabletSCD23deb5f1-d357-45af-9851-d1249bdfa6dd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-773-0160687077301100 BLISTER PACK in 1 CARTON (60687-773-01) / 1 TABLET in 1 BLISTER PACK (60687-773-11) 100 blister pack2023-12-01NoNoCurrent
60687-773-11606870773111 in 1 BLISTER PACKHistorical