Home NDC 80425-0261-1 Dexamethasone Sodium Phosphate
Product NDC 80425-0261
Requested package NDC 80425-0261-1
11-digit product format 804250261
Labeler code 80425
Product ID 80425-0261_2a9bad62-b2fd-697c-e063-6294a90aa395
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone Sodium Phosphate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA207442
Marketing category ANDA
Marketing start 2023-02-16
Substance DEXAMETHASONE SODIUM PHOSPHATE
Active strength 10 mg/mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207442-001 AP
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207442-001 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2018-04-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Dexamethasone Sodium Phosphate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AI9376Y64P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1812079 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 80425-0261-1 Dexamethasone Sodium Phosphate 25 in 1 CARTON INJECTION 25 2 80425-0261-1 Dexamethasone Sodium Phosphate 1 mL in 1 VIAL INJECTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0261 DEXAMETHASONE SODIUM PHOSPHATE INJECTION [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 2 Current NDC, 2 package rows 20250102_f4d6c7c8-7a77-6a46-e053-2995a90a4411.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 80425-0261-1 80425026101 25 VIAL in 1 CARTON (80425-0261-1) / 1 mL in 1 VIAL 25 vial 2023-02-16 No No Current