Home NDC 80425-0346 Dexamethasone
Product NDC 80425-0346
11-digit product format 804250346
Labeler code 80425
Product ID 80425-0346_4250a0b0-e539-57c9-e063-6294a90a4b55
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form TABLET
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA201270
Marketing category ANDA
Marketing start 2023-07-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201270-001 DEXAMETHASONE DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201270-001 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.
Product history page 1 of 2 · 43 observed 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 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201270-001 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2017-07-17 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 1.5 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 197580 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 80425-0346-1 Dexamethasone 21 in 1 BOTTLE TABLET 21 3 80425-0346-2 Dexamethasone 27 in 1 BOTTLE TABLET 27 3 80425-0346-3 Dexamethasone 49 in 1 BOTTLE TABLET 49 3 80425-0346-4 Dexamethasone 60 in 1 BOTTLE TABLET 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0346 DEXAMETHASONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 2 Current NDC, 4 package rows 20250102_01cfaa3e-5e30-18fa-e063-6394a90a084e.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dexamethasone DEXAMETHASONE Advanced Rx Pharmacy of Tennessee, LLC 01cfaa3e-5e30-18fa-e063-6394a90a084e 2025-10-29 Warnings, Adverse reactions Exact identifier application applno (ANDA): 201270 application number: ANDA201270 ndc (product): 80425-0346 Dexamethasone 1.5 mg DEXAMETHASONE 1.5 MG Larken Laboratories, Inc. 7b997c26-e6a3-403c-93fb-b1290cf5dbad 2025-10-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 201270 application number: ANDA201270 Dexamethasone 1.5 mg DEXAMETHASONE 1.5 MG Larken Laboratories, Inc. fcc75691-974e-4a67-b9d7-64dde72b5595 2025-10-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 201270 application number: ANDA201270 Dexamethasone DEXAMETHASONE Proficient Rx LP 45fd8030-dbe3-4da4-9d0a-6549cf4f7359 2024-07-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 201270 application number: ANDA201270 Dexamethasone 1.5 mg DEXAMETHASONE 1.5 MG Proficient Rx LP 42db0356-3948-444c-bda3-1226b4ca8985 2024-01-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 201270 application number: ANDA201270
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80425-0346-1 80425034601 21 TABLET in 1 BOTTLE (80425-0346-1) 21 tablet 2023-07-31 No No Current 80425-0346-2 80425034602 27 TABLET in 1 BOTTLE (80425-0346-2) 27 tablet 2023-07-31 No No Current 80425-0346-3 80425034603 49 TABLET in 1 BOTTLE (80425-0346-3) 49 tablet 2023-07-31 No No Current 80425-0346-4 80425034604 60 TABLET in 1 BOTTLE (80425-0346-4) 60 tablet 2025-10-28 No No Current