Dexamethasone Tablets, USP

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-05-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:03:37

Label at a glance#

ProductDexamethasone
Active ingredientDEXAMETHASONE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1706-1

Dexamethasone Tablets, USP 1 mg

100 Tablets

Rx only

dexamethasone tablets 1 mg
dexamethasone tablets 1 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197579dexAMETHasone 1 MG Oral TabletPSN1
197579dexamethasone 1 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXAMETHASONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
70771-1706-1Dexamethasone100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1706DEXAMETHASONE TABLET [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 1 package rows20240517_e9012a11-6219-4272-aea2-b7328bbcf523.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-170670771-1706-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A216284-001DEXAMETHASONEDEXAMETHASONE1MGTABLET / ORALAB2024-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216284-001AB

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
2026-09-14 22:38:342026-08A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-0984e616aacf4f…
2026-08-18 06:07:402026-07A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-091e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216284-001DEXAMETHASONE1MGTABLET / ORALAB2024-05-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216284-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A216284-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216284-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216284-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216284-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216284-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216284-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216284-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216284-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216284-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216284-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216284-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216284-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216284-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216284-001AB11e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216284-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONEZydus Lifesciences Limitede9012a11-6219-4272-aea2-b7328bbcf5232024-05-13Exact identifier
ndc (package): 70771-1706-1
ndc (product): 70771-1706
ndc11 (package): 70771170601
spl id: 232c68af-fb83-4b93-9e16-9803c8e680c0
spl set id: e9012a11-6219-4272-aea2-b7328bbcf523

Reported adverse events (FAERS/openFDA)#

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