Application 021150

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ZYRTEC-D 12 HOUR	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;120MG	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021150-002	ZYRTEC-D 12 HOUR	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2007-11-09

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021150-002	7014867	2022-06-10		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021150-002	7226614	2022-06-10	U-295		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021150-002	7014867	2022-06-10		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021150-002	7226614	2022-06-10	U-295		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021150-002	7014867	2022-06-10		Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021150-002	7226614	2022-06-10	U-295		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021150-002	6469009	2019-07-13	U-295	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021150-002	7014867	2022-06-10		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021150-002	7226614	2022-06-10	U-295		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021150-002	7014867	2022-06-10		Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021150-002	7226614	2022-06-10	U-295		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021150-002	7014867	2022-06-10		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021150-002	7226614	2022-06-10	U-295		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021150-002	7014867	2022-06-10		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021150-002	7226614	2022-06-10	U-295		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021150-002	7014867	2022-06-10		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021150-002	7226614	2022-06-10	U-295		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021150-002	7014867	2022-06-10		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021150-002	7226614	2022-06-10	U-295		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021150-002	7014867	2022-06-10		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021150-002	7226614	2022-06-10	U-295		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021150-002	6469009	2019-07-13	U-295	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021150-002	7014867	2022-06-10		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021150-002	7226614	2022-06-10	U-295		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021150-002	6469009	2019-07-13	U-295	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021150-002	7014867	2022-06-10		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021150-002	7226614	2022-06-10	U-295		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021150-002	6469009	2019-07-13	U-295	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021150-002	7014867	2022-06-10		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021150-002	7226614	2022-06-10	U-295		`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021150-002	7014867	2022-06-10		Drug product	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021150-002	7226614	2022-06-10	U-295		`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021150-002	7014867	2022-06-10		Drug product	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021150-002	7226614	2022-06-10	U-295		`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021150-002	7014867	2022-06-10		Drug product	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021150-002	7226614	2022-06-10	U-295		`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021150-002	7014867	2022-06-10		Drug product	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021150-002	7226614	2022-06-10	U-295		`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021150-002	7014867	2022-06-10		Drug product	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021150-002	7226614	2022-06-10	U-295		`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZYRTEC-D	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	f1ecf9ba-1c03-7fb7-e053-2a95a90a875a	2026-04-06	Warnings	Exact identifier application applno (NDA): 021150 application number: NDA021150
ZYRTEC-D Allergy Plus Congestion	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	1e8eb279-3522-40e4-8062-06b5354f0d29	2025-06-12	Warnings	Exact identifier application applno (NDA): 021150 application number: NDA021150 ndc (product): 50580-728

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50580-728	ZYRTEC-D	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-728	ZYRTEC-D	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-728	ZYRTEC-D	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-728	ZYRTEC-D	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79606	SUPPL	2024-09-16
79605	SUPPL	2024-09-16
69330	SUPPL	2021-11-16
69236	SUPPL	2021-11-05
21478	SUPPL	2008-05-21
26910	SUPPL	2007-11-13
14507	SUPPL	2004-04-05
4474	SUPPL	2004-03-24
4473	SUPPL	2003-05-29
14506	SUPPL	2003-04-17
41986	ORIG	2001-08-10
26909	ORIG	2001-08-10
14505	ORIG	2001-08-10