ReadySharp Dexamethasone

Product NDC: 53225-3660
Requested package NDC: 53225-3660-1
11-digit product format: 532253660
Labeler code: 53225
Product ID: 53225-3660_cdc8226e-dc57-3ad6-e053-2a95a90a7e41
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone Sodium Phosphate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Terrain Pharmaceuticals
Application: ANDA087702
Marketing category: ANDA
Marketing start: 1982-09-07
Marketing end: 0000-00-00
Substance: DEXAMETHASONE SODIUM PHOSPHATE
Active strength: 10 mg/mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53225-3660	53225-3660-1	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087702-001	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	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087702-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087702-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087702-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087702-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087702-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087702-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087702-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087702-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087702-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087702-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087702-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087702-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087702-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087702-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087702-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087702-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087702-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087702-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087702-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087702-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087702-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087702-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087702-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087702-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087702-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087702-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087702-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087702-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087702-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087702-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087702-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087702-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087702-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087702-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087702-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087702-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087702-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087702-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087702-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087702-001	AP	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53225-3660-1	EA - Each	53225-3660	f430d485-4890-44e0-9ebd-0467d3a9e904	1	2016-12-07

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Cardinal Health 107, LLC	7a7ee007-cd02-4f3f-8f0f-82c4964da6e6	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	REMEDYREPACK INC.	6ea9e6ab-0d33-4635-9e98-aa2fbd8921cc	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	0e4f0f22-e6a1-4725-addb-0cc91bed07e9	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Hikma Pharmaceuticals USA Inc.	0277cc0a-2fd4-4605-a310-b613be84ee26	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Civica, Inc.	d54a27f2-2af8-4f86-a7fd-453f6b1a9997	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	7da9da65-0c03-23e2-e053-2a91aa0a042f	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	69344707-904d-7ba2-e053-2a91aa0a31f4	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AI9376Y64P	DEXAMETHASONE SODIUM PHOSPHATE	2392-39-4	DEXAMETHASONE SODIUM PHOSPHATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53225-3660-1	53225366001	1 mL in 1 VIAL (53225-3660-1)	1 ml	2016-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ReadySharp Dexamethasone	Terrain Pharmaceuticals	2021-10-07	HUMAN PRESCRIPTION DRUG LABEL	6
ReadySharp Dexamethasone	Preferred Pharmaceuticals, Inc.	2019-12-17	HUMAN PRESCRIPTION DRUG LABEL	1