Dexmedetomidine Hydrochloride

Product NDC: 63323-671
Requested package NDC: 63323-671-20
11-digit product format: 633230671
Labeler code: 63323
Product ID: 63323-671_27411591-44a1-44c4-89c3-dd8c2687f0e2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmedetomidine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA208129
Marketing category: ANDA
Marketing start: 2019-05-13
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: 2026-12-31
Current FDA listing: Yes

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	63323-671	63323-671-20	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29
A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29
A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208129-001	AP
A208129-002	AP
A208129-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208129-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208129-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208129-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2018-11-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208129-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208129-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208129-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208129-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208129-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208129-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208129-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208129-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208129-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208129-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208129-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208129-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208129-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208129-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208129-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208129-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208129-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208129-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208129-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208129-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208129-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208129-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208129-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208129-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208129-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208129-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208129-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208129-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208129-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208129-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208129-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208129-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208129-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208129-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208129-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208129-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208129-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208129-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208129-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208129-001	AP	1	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A208129-001	PC	2019-11-30	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A208129-001	PC	2019-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208129-001	PC	2019-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208129-001	PC	2019-11-30	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ec136f1-cd53-4b90-826e-3eaeec54dca0	Product name	2	20250401
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
acae4bed-c293-9f7e-61b9-d68b8475ed3a	Product name	2	20230104
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
536fa340-f745-6c4e-1ad7-a3c414722bcc	Product name	9	20170706
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-671-00	Dexmedetomidine Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10	5
63323-671-01	Dexmedetomidine Hydrochloride	100 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	100	5
63323-671-02	Dexmedetomidine Hydrochloride	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	20	5
63323-671-05	Dexmedetomidine Hydrochloride	50 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	50	5
63323-671-20	Dexmedetomidine Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10	5
63323-671-50	Dexmedetomidine Hydrochloride	25 in 1 CARTON	INJECTION, SOLUTION	25	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-671-00	ML - Milliliter	63323-671	40beb3f6-7bc2-48d6-933f-201ee2763ffc	1	2019-06-19
63323-671-01	ML - Milliliter	63323-671	59fcd655-1d1c-4b59-af8b-d0d4cdc5536b	1	2019-06-19
63323-671-02	ML - Milliliter	63323-671	bb1dbc22-6c23-4e76-9e6e-4e656842f2f7	1	2019-06-19
63323-671-05	ML - Milliliter	63323-671	6fa96e9c-0fb2-4df4-9be0-b5ffb28f88c2	1	2019-06-19
63323-671-20	ML - Milliliter	63323-671	7ef08756-32f8-4501-9653-40be400a983c	1	2019-06-19
63323-671-50	ML - Milliliter	63323-671	ffa8f1d9-5954-470e-8537-30660fbece3f	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-671	DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	5	Current NDC, Legacy NDC, 6 package rows	20240518_4d5d2294-89a0-4b6f-aa00-d39a0393b6a8.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	4d5d2294-89a0-4b6f-aa00-d39a0393b6a8	5
1718909	dexmedeTOMIDine HCl 400 MCG in 100 ML Injection	PSN	4d5d2294-89a0-4b6f-aa00-d39a0393b6a8	5
1718900	dexmedeTOMIDine HCl 80 MCG in 20 ML Injection	PSN	4d5d2294-89a0-4b6f-aa00-d39a0393b6a8	5
1718909	100 ML dexmedetomidine 0.004 MG/ML Injection	SCD	4d5d2294-89a0-4b6f-aa00-d39a0393b6a8	5
1718900	20 ML dexmedetomidine 0.004 MG/ML Injection	SCD	4d5d2294-89a0-4b6f-aa00-d39a0393b6a8	5
1718906	50 ML dexmedetomidine 0.004 MG/ML Injection	SCD	4d5d2294-89a0-4b6f-aa00-d39a0393b6a8	5
1718906	dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML Injection	SY	4d5d2294-89a0-4b6f-aa00-d39a0393b6a8	5
1718909	dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML Injection	SY	4d5d2294-89a0-4b6f-aa00-d39a0393b6a8	5
1718900	dexmedetomidine (as dexmedetomidine HCl) 80 MCG per 20 ML Injection	SY	4d5d2294-89a0-4b6f-aa00-d39a0393b6a8	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-671-20	63323067120	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-671-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-671-02)	2019-05-13	0000-00-00	No	No	Current