Clonidine Hydrochloride

Product NDC: 40042-053
11-digit product format: 400420053
Labeler code: 40042
Product ID: 40042-053_f89df25e-bb64-4351-b3b4-c3eb34843648
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonidine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL
Labeler: PharmaForce, Inc.
Application: ANDA091104
Marketing category: ANDA
Marketing start: 2009-10-16
Marketing end: 0000-00-00
Substance: CLONIDINE HYDROCHLORIDE
Active strength: 500 ug/mL
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	40042-053		I	Inactivated by FDA		2026-08-17
excluded package	package	40042-053	40042-053-10	I	Inactivated by FDA		2026-08-17

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 · 44 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40042-053-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40042-053-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40042-053-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40042-053-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40042-053-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40042-053-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40042-053-10	`302b2466d912…`	`e7b80fea0513…`
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	40042-053-10	`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	40042-053-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	40042-053-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	40042-053-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	40042-053-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	40042-053-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	40042-053-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	40042-053-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	40042-053-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	40042-053-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	40042-053-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	40042-053-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	40042-053-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	40042-053-10	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	40042-053-10	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091104-001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION			2009-10-08
A091104-002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION			2009-10-08

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091104-001	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	2009-10-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091104-002	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	2009-10-08	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
45c8ba14-e378-46f0-b21f-1aad8e08c613	Product name	1	20250221
6920b0ed-30bc-b127-73e1-0713049bd41e	Product name	9	20190618
6920b0ed-30bc-b127-73e1-0713049bd41e	Product name	5	20171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789	Product name	2	20150123
624cf764-e200-44b5-83c2-84526255adb5	Product name	1	20150107
47972e1b-c905-eeee-5e77-eb4538ad833c	Product name	1	20140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40042-053-10	2019-10-21	C162847	48780-1	956f9ecf-cba9-621f-e053-dbdaa90a74ad	CLONIDINE HYDROCHLORIDE INJECTION Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
40042-053-10	Clonidine Hydrochloride	10 mL in 1 VIAL	INJECTION, SOLUTION	10		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLONIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	W76I6XXF06	CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	2
CLONIDINE	ACTIVE MOIETY	MN3L5RMN02	CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40042-053	CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	2	Legacy NDC, 1 package rows	20091020_6e562c90-2e37-47ac-9c3f-12460f96dc33.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W76I6XXF06	CLONIDINE HYDROCHLORIDE	4205-91-8	CLONIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
884221	cloNIDine HCl 1000 MCG in 10 ML Injection	PSN	6e562c90-2e37-47ac-9c3f-12460f96dc33	2
884225	cloNIDine HCl 5000 MCG in 10 ML Injection	PSN	6e562c90-2e37-47ac-9c3f-12460f96dc33	2
884221	10 ML clonidine hydrochloride 0.1 MG/ML Injection	SCD	6e562c90-2e37-47ac-9c3f-12460f96dc33	2
884225	10 ML clonidine hydrochloride 0.5 MG/ML Injection	SCD	6e562c90-2e37-47ac-9c3f-12460f96dc33	2
884221	clonidine HCl 1000 MCG per 10 ML Injection	SY	6e562c90-2e37-47ac-9c3f-12460f96dc33	2
884225	clonidine HCl 5000 MCG per 10 ML Injection	SY	6e562c90-2e37-47ac-9c3f-12460f96dc33	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
40042-053-10	40042005310	10 mL in 1 VIAL	10 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLONIDINE HYDROCHLORIDE INJECTION Rx only	PharmaForce, Inc. \| Marilyn Friedly	2009-10-19	HUMAN PRESCRIPTION DRUG LABEL	2