Dexmedetomidine Hydrochloride in Sodium Chloride

Product NDC: 51224-215
Requested package NDC: 51224-215-10
11-digit product format: 512240215
Labeler code: 51224
Product ID: 51224-215_b654e5e9-102d-4623-80ad-5af3372427b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmedetomidine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: TAGI Pharma, Inc.
Application: ANDA212857
Marketing category: ANDA
Marketing start: 2020-11-23
Marketing end: 0000-00-00
Substance: DEXMEDETOMIDINE HYDROCHLORIDE
Active strength: 4 ug/mL
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]
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	51224-215	51224-215-10	D	Discontinued by firm		2026-08-10

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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23
A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23
A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212857-001	AP
A212857-002	AP
A212857-003	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 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212857-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212857-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212857-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-11-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	A212857-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212857-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212857-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212857-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212857-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212857-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212857-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212857-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212857-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212857-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212857-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212857-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212857-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212857-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212857-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212857-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212857-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212857-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212857-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212857-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212857-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212857-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212857-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212857-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212857-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212857-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212857-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212857-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212857-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212857-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212857-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212857-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212857-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212857-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212857-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212857-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212857-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212857-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212857-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212857-001	AP	1	`8072bd15b7f6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmedetomidine Hydrochloride in Sodium Chloride	DEXMEDETOMIDINE HYDROCHLORIDE	Precision Dose, Inc.	e9d5c989-ebf6-4377-9c6e-7aef848a03a1	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212857 application number: ANDA212857

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1018WH7F9I	DEXMEDETOMIDINE HYDROCHLORIDE	145108-58-3	DEXMEDETOMIDINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51224-215-10	51224021510	10 BOTTLE in 1 CARTON (51224-215-10) > 100 mL in 1 BOTTLE (51224-215-01)	10 bottle	2020-11-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmedetomidine Hydrochloride in Sodium Chloride	TAGI Pharma, Inc. \| Corden Pharma SPA	2021-11-01	HUMAN PRESCRIPTION DRUG LABEL	6