DEXMEDETOMIDINE HYDROCHLORIDE

Product NDC: 71225-126
11-digit product format: 712250126
Labeler code: 71225
Product ID: 71225-126_c04838c9-3b1c-46db-b544-e86f10029891
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexmedetomidine hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Slayback Pharma LLC
Application: ANDA212791
Marketing category: ANDA
Marketing start: 2019-12-06
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: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71225-126		D	Discontinued by firm	2026-10-21
excluded package	package	71225-126	71225-126-04	D	Discontinued by firm	2026-10-21
excluded package	package	71225-126	71225-126-05	D	Discontinued by firm	2026-10-21
excluded package	package	71225-126	71225-126-06	D	Discontinued by firm	2026-10-21

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71225-126-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71225-126-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71225-126-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71225-126-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71225-126-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71225-126-05	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04
A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04
A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212791-001	AP
A212791-002	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 4 · 121 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
2026-10-15 13:18:30	2026-09	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212791-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212791-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION		2020-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212791-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2019-12-04	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A212791-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212791-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212791-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212791-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212791-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212791-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212791-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212791-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212791-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212791-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212791-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212791-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212791-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212791-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212791-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212791-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212791-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212791-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212791-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212791-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212791-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212791-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212791-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212791-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212791-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212791-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212791-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212791-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212791-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212791-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212791-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212791-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212791-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212791-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212791-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212791-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212791-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212791-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212791-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212791-002	AP	1	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ec136f1-cd53-4b90-826e-3eaeec54dca0	Product name	2	20250401
acae4bed-c293-9f7e-61b9-d68b8475ed3a	Product name	2	20230104
536fa340-f745-6c4e-1ad7-a3c414722bcc	Product name	9	20170706
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71225-126-01	DEXMEDETOMIDINE HYDROCHLORIDE	20 mL in 1 VIAL	INJECTION	20	10
71225-126-02	DEXMEDETOMIDINE HYDROCHLORIDE	50 mL in 1 BOTTLE	INJECTION	50	10
71225-126-03	DEXMEDETOMIDINE HYDROCHLORIDE	100 mL in 1 BOTTLE	INJECTION	100	10
71225-126-04	DEXMEDETOMIDINE HYDROCHLORIDE	10 in 1 CARTON	INJECTION	10	10
71225-126-05	DEXMEDETOMIDINE HYDROCHLORIDE	20 in 1 CARTON	INJECTION	20	10
71225-126-06	DEXMEDETOMIDINE HYDROCHLORIDE	10 in 1 CARTON	INJECTION	10	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71225-126-02	ML - Milliliter	71225-126	14c0e938-bf9f-4e78-a481-c74d96394de4	1	2020-01-03
71225-126-03	ML - Milliliter	71225-126	139017dc-5564-490a-9dd4-5ce1f81ebc93	1	2020-01-03
71225-126-05	ML - Milliliter	71225-126	ed3ee683-648d-4ae3-b002-7abb76f60404	1	2020-01-03
71225-126-06	ML - Milliliter	71225-126	c8e2f3ab-fcab-4c14-ae1d-d65e9638adbb	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71225-126	DEXMEDETOMIDINE HYDROCHLORIDE INJECTION [SLAYBACK PHARMA LLC]	10	Legacy NDC, 6 package rows	20250130_e5d28ed8-e427-4850-81aa-98702d3b6a5d.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1718906	dexmedeTOMIDine HCl 200 MCG in 50 ML Injection	PSN	e5d28ed8-e427-4850-81aa-98702d3b6a5d	10
1718909	dexmedeTOMIDine HCl 400 MCG in 100 ML Injection	PSN	e5d28ed8-e427-4850-81aa-98702d3b6a5d	10
1718900	dexmedeTOMIDine HCl 80 MCG in 20 ML Injection	PSN	e5d28ed8-e427-4850-81aa-98702d3b6a5d	10
1718909	100 ML dexmedetomidine 0.004 MG/ML Injection	SCD	e5d28ed8-e427-4850-81aa-98702d3b6a5d	10
1718900	20 ML dexmedetomidine 0.004 MG/ML Injection	SCD	e5d28ed8-e427-4850-81aa-98702d3b6a5d	10
1718906	50 ML dexmedetomidine 0.004 MG/ML Injection	SCD	e5d28ed8-e427-4850-81aa-98702d3b6a5d	10
1718906	dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML Injection	SY	e5d28ed8-e427-4850-81aa-98702d3b6a5d	10
1718909	dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML Injection	SY	e5d28ed8-e427-4850-81aa-98702d3b6a5d	10
1718900	dexmedetomidine (as dexmedetomidine HCl) 80 MCG per 20 ML Injection	SY	e5d28ed8-e427-4850-81aa-98702d3b6a5d	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71225-126-01	71225012601	20 mL in 1 VIAL	20 ml					Historical
71225-126-02	71225012602	50 mL in 1 BOTTLE	50 ml					Historical
71225-126-03	71225012603	100 mL in 1 BOTTLE	100 ml					Historical
71225-126-04	71225012604	10 VIAL in 1 CARTON (71225-126-04) > 20 mL in 1 VIAL (71225-126-01)	10 vial	2021-12-11	0000-00-00	No	No	Current
71225-126-05	71225012605	20 BOTTLE in 1 CARTON (71225-126-05) > 50 mL in 1 BOTTLE (71225-126-02)	20 bottle	2019-12-06	0000-00-00	No	No	Current
71225-126-06	71225012606	10 BOTTLE in 1 CARTON (71225-126-06) > 100 mL in 1 BOTTLE (71225-126-03)	10 bottle	2019-12-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXMEDETOMIDINE HYDROCHLORIDE	Slayback Pharma LLC \| Corden Pharma SpA	2024-12-12	Human Prescription Drug Label	10