Home NDC 70771-1706-1 Dexamethasone
Product NDC 70771-1706
Requested package NDC 70771-1706-1
11-digit product format 707711706
Labeler code 70771
Product ID 70771-1706_232c68af-fb83-4b93-9e16-9803c8e680c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form TABLET
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA216284
Marketing category ANDA
Marketing start 2024-05-13
Substance DEXAMETHASONE
Active strength 1 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216284-001 DEXAMETHASONE DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216284-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216284-001 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-05-09 a50c72e98297…
Observed Orange Book normalized TE history# 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 Ingredient Strength DEXAMETHASONE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7S5I7G3JQL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197579 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70771-1706-1 Dexamethasone 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1706 DEXAMETHASONE TABLET [ZYDUS LIFESCIENCES LIMITED] 1 Current NDC, 1 package rows 20240517_e9012a11-6219-4272-aea2-b7328bbcf523.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70771-1706-1 70771170601 100 TABLET in 1 BOTTLE (70771-1706-1) 100 tablet 2024-05-13 No No Current