Home NDC 63323-516 Dexamethasone Sodium Phosphate
Product NDC 63323-516
11-digit product format 633230516
Labeler code 63323
Product ID 63323-516_9320abbb-bfd8-4df2-9269-3a52736c190f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEXAMETHASONE SODIUM PHOSPHATE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA040572
Marketing category ANDA
Marketing start 2005-04-05
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 2027-12-31
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 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040572-001 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 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040572-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE / INJECTION AP RS 2005-04-22 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 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309696 Internal RxNorm lookup 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 63323-516-01 Dexamethasone Sodium Phosphate 10 mL in 1 VIAL INJECTION, SOLUTION 10 11 63323-516-10 Dexamethasone Sodium Phosphate 10 in 1 TRAY INJECTION, SOLUTION 10 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXAMETHASONE SODIUM PHOSPHATE ACTIVE INGREDIENT AI9376Y64P DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 DEXAMETHASONE ACTIVE MOIETY 7S5I7G3JQL DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-516 DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 9 Current NDC, Legacy NDC, 2 package rows 20240725_cca2c160-9188-48e8-9505-49a52388dcb7.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 Marketing end Sample Exclude flag Status 63323-516-01 63323051601 10 mL in 1 VIAL 10 ml Historical 63323-516-10 63323051610 10 VIAL in 1 TRAY (63323-516-10) / 10 mL in 1 VIAL (63323-516-01) 10 vial 2005-04-05 0000-00-00 No No Current