Home NDC 70518-4372 Dexamethasone Sodium Phosphate
Product NDC 70518-4372
11-digit product format 705184372
Labeler code 70518
Product ID 70518-4372_3867dcb2-3f87-722f-e063-6294a90abd06
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone Sodium Phosphate
Dosage form INJECTION, SOLUTION
Route INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler REMEDYREPACK INC.
Application ANDA215654
Marketing category ANDA
Marketing start 2025-06-25
Substance DEXAMETHASONE SODIUM PHOSPHATE
Active strength 4 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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215654-001 DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 55 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 2026-08-18 06:07:40 2026-07 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215654-002 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215654-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2021-08-04 ea1830bbd6c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 55 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 4 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 1812194 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 70518-4372-0 Dexamethasone Sodium Phosphate 25 in 1 CARTON INJECTION, SOLUTION 25 1 70518-4372-1 Dexamethasone Sodium Phosphate 1 mL in 1 VIAL INJECTION, SOLUTION 1 1
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 · 4 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 70518-4372-0 70518437200 25 VIAL in 1 CARTON (70518-4372-0) / 1 mL in 1 VIAL (70518-4372-1) 25 vial 2025-06-25 No No Current 70518-4372-1 70518437201 1 mL in 1 VIAL 1 ml Historical