Home NDC 72485-118 Dexamethasone Sodium Phosphate
Product NDC 72485-118
11-digit product format 724850118
Labeler code 72485
Product ID 72485-118_9fac7843-5bd2-4682-8d09-b2169a7add79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone Sodium Phosphate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Armas Pharmaceuticals
Application ANDA217797
Marketing category ANDA
Marketing start 2025-04-22
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 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217797-001 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.
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 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217797-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2024-03-27 a50c72e98297…
Observed Orange Book normalized TE history# 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 72485-118-01 Dexamethasone Sodium Phosphate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 1 72485-118-25 Dexamethasone Sodium Phosphate 25 in 1 CARTON INJECTION, SOLUTION 25 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72485-118 DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [ARMAS PHARMACEUTICALS] 1 Current NDC, 2 package rows 20250429_0ce0211c-86fa-4056-b161-0950639df6d8.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 72485-118-01 72485011801 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 72485-118-25 72485011825 25 VIAL, SINGLE-DOSE in 1 CARTON (72485-118-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-118-01) 2025-04-22 No No Current