APTRIZINE

Product NDC: 46084-012
11-digit product format: 460840012
Labeler code: 46084
Product ID: 46084-012_113f7b27-dc67-473f-80ed-275c08320439
Type: HUMAN OTC DRUG
Nonproprietary name: CETIRIZINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: A P J Laboratories Limited
Application: ANDA019835
Marketing category: ANDA
Marketing start: 2013-02-21
Marketing end: 0000-00-00
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	46084-012		I	Inactivated by FDA	2026-08-17
excluded package	package	46084-012	46084-012-11	I	Inactivated by FDA	2026-08-17
excluded package	package	46084-012	46084-012-12	I	Inactivated by FDA	2026-08-17
excluded package	package	46084-012	46084-012-13	I	Inactivated by FDA	2026-08-17
excluded package	package	46084-012	46084-012-14	I	Inactivated by FDA	2026-08-17
excluded package	package	46084-012	46084-012-15	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 3 · 132 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	46084-012-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-012-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-012-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-012-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-012-15	`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	46084-012-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-012-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-012-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-012-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-012-15	`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	46084-012-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-012-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-012-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-012-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-012-15	`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	46084-012-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-012-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-012-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-012-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-012-15	`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	46084-012-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-012-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-012-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-012-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-012-15	`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	46084-012-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-012-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-012-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-012-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-012-15	`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	46084-012-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-012-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-012-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-012-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-012-15	`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	46084-012-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-012-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-012-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-012-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-012-15	`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	46084-012-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46084-012-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46084-012-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46084-012-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46084-012-15	`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	46084-012-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46084-012-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46084-012-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46084-012-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46084-012-15	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
46084-012-11	22e5db90-4cee-47af-9e3e-3636d99974ba
46084-012-12	22e5db90-4cee-47af-9e3e-3636d99974ba
46084-012-13	22e5db90-4cee-47af-9e3e-3636d99974ba
46084-012-14	22e5db90-4cee-47af-9e3e-3636d99974ba
46084-012-15	22e5db90-4cee-47af-9e3e-3636d99974ba

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46084-012-11	APTRIZINE24-HOUR ALL DAY ALLERGY	15 in 1 BLISTER PACK	TABLET	15	2
46084-012-12	APTRIZINE24-HOUR ALL DAY ALLERGY	30 in 1 BLISTER PACK	TABLET	30	2
46084-012-13	APTRIZINE24-HOUR ALL DAY ALLERGY	45 in 1 BLISTER PACK	TABLET	45	2
46084-012-14	APTRIZINE24-HOUR ALL DAY ALLERGY	60 in 1 BLISTER PACK	TABLET	60	2
46084-012-15	APTRIZINE24-HOUR ALL DAY ALLERGY	120 in 1 BLISTER PACK	TABLET	120	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]	2
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46084-012	APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]	2	Legacy NDC, 5 package rows	20130221_22e5db90-4cee-47af-9e3e-3636d99974ba.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
64O047KTOA	CETIRIZINE HYDROCHLORIDE	83881-52-1	CETIRIZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	22e5db90-4cee-47af-9e3e-3636d99974ba	2
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	22e5db90-4cee-47af-9e3e-3636d99974ba	2
1014678	cetirizine HCl 10 MG Oral Tablet	SY	22e5db90-4cee-47af-9e3e-3636d99974ba	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
46084-012-11	46084001211	15 in 1 BLISTER PACK	Historical
46084-012-12	46084001212	30 in 1 BLISTER PACK	Historical
46084-012-13	46084001213	45 in 1 BLISTER PACK	Historical
46084-012-14	46084001214	60 in 1 BLISTER PACK	Historical
46084-012-15	46084001215	120 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
APTRIZINE 24-HOUR ALL DAY ALLERGY - A P J Laboratories Limited	A P J Laboratories Limited	2013-02-21	HUMAN OTC DRUG LABEL	2