Dexamethasone Sodium Phosphate

Product NDC
25021-053
11-digit product format
250210053
Labeler code
25021
Product ID
25021-053_688efb4d-213e-453d-add7-9875a6a19485
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler
Sagent Pharmaceuticals
Application
ANDA215654
Marketing category
ANDA
Marketing start
2024-12-01
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215654-001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-04
A215654-002DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A215654-001AP
A215654-002AP

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 · 53 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-044b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-04782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-046a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-041c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-04ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215654-002DEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2023-09-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215654-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTIONAP2021-08-04a72a2bbeb626…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215654-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215654-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215654-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215654-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215654-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215654-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215654-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215654-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215654-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215654-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215654-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215654-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215654-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215654-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215654-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215654-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215654-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215654-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215654-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215654-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215654-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215654-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215654-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215654-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215654-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215654-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215654-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215654-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215654-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215654-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215654-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215654-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215654-001AP1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215654-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215654-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215654-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215654-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215654-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215654-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215654-001AP1a72a2bbeb626…

Additional Listing Data#

Finished product
Yes
Brand name base
Dexamethasone Sodium Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE SODIUM PHOSPHATE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AI9376Y64PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1116927Internal RxNorm lookup
1812079Internal RxNorm lookup
1812194Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4680d517-ed5a-4137-819c-122ee962a464Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-053-01Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION, SOLUTION11
25021-053-01Dexamethasone Sodium Phosphate25 in 1 CARTONINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-053-01ML - Milliliter25021-0532824efa5-b56e-4b4a-a291-2060396a8ad912025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-053DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20241215_4680d517-ed5a-4137-819c-122ee962a464.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC.41eb3b4a-3386-ebfa-e063-6394a90a4dba2025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215654
application number: ANDA215654
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEREMEDYREPACK INC.11f10a47-1c42-40e4-89d8-bb000fef497c2025-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215654
application number: ANDA215654
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESagent Pharmaceuticals4680d517-ed5a-4137-819c-122ee962a4642024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215654
application number: ANDA215654
ndc (product): 25021-053
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEGland Pharma Limitedc9d9ab76-6bc6-433d-aad7-8d49064ed7452024-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215654
application number: ANDA215654

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812079dexAMETHasone sodium phosphate 10 MG in 1 ML InjectionPSN4680d517-ed5a-4137-819c-122ee962a4641
1812194dexAMETHasone sodium phosphate 4 MG in 1 ML InjectionPSN4680d517-ed5a-4137-819c-122ee962a4641
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSN4680d517-ed5a-4137-819c-122ee962a4641
18120791 ML dexamethasone phosphate 10 MG/ML InjectionSCD4680d517-ed5a-4137-819c-122ee962a4641
18121941 ML dexamethasone phosphate 4 MG/ML InjectionSCD4680d517-ed5a-4137-819c-122ee962a4641
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCD4680d517-ed5a-4137-819c-122ee962a4641
1812079dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML InjectionSY4680d517-ed5a-4137-819c-122ee962a4641
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSY4680d517-ed5a-4137-819c-122ee962a4641
1812194dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 ML InjectionSY4680d517-ed5a-4137-819c-122ee962a4641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-053-012502100530125 VIAL in 1 CARTON (25021-053-01) / 1 mL in 1 VIAL25 vial2024-12-01NoNoCurrent