Application 022429
- Type
- NDA
- Sponsor
- BIONPHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | CAPSULE;ORAL | 5MG | Yes | No |
| 002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | CAPSULE;ORAL | 10MG | Yes | Yes |
| 003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | CAPSULE;ORAL | 5MG | Yes | No |
| 004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | CAPSULE;ORAL | 10MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | |
| N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | |
| N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | |
| N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | d06236e962d9… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cetirizine HCl | CETIRIZINE HCL | AMERISOURCE BERGEN | 75f2649d-005e-4f16-a7c3-ae966f3a7a00 | 2022-05-19 | Warnings | 022429 NDA022429 46122-613 |
| all day allergy | CETIRIZINE HCL | SUPERVALU INC | ca0da001-0d38-43e9-8ab1-c7c217f88bce | 2018-12-31 | Warnings | 022429 NDA022429 41163-219 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-0211 | 24 Hour Allergy | Cetirizine HCl | Walgreens | NDA | Current |
| 0363-0211 | Wal-Zyr | Cetirizine HCl | Walgreens | NDA | Current |
| 0363-0921 | Wal-Zyr | Cetirizine HCl | Walgreens | NDA | Current |
| 0363-0921 | Allergy Relief | Cetirizine HCl | Walgreens | NDA | Current |
| 0363-0921 | Wal-Zyr | Cetirizine HCl | Walgreens | NDA | Current |
| 0363-0921 | Wal-Zyr | Cetirizine HCl | Walgreens | NDA | Current |
| 0363-1219 | 24 Hour Allergy | Cetirizine HCl | Walgreens | NDA | Current |
| 0363-1219 | 24 HOUR ALLERGY | Cetirizine HCl | Walgreens | NDA | Current |
| 0363-1219 | 24 HOUR ALLERGY | Cetirizine HCl | Walgreens | NDA | Current |
| 0363-1219 | 24 Hour Allergy | Cetirizine HCl | Walgreens | NDA | Current |
| 11673-211 | Allergy Relief | Cetirizine HCl | TARGET Corporation | NDA | Current |
| 11673-211 | Allergy Relief | Cetirizine HCl | TARGET Corporation | NDA | Current |
| 11673-242 | Cetirizine HCl | Cetirizine HCl | TARGET Corporation | NDA | Current |
| 11673-242 | Cetirizine HCl | Cetirizine HCl | TARGET Corporation | NDA | Current |
| 30142-211 | All Day Allergy | Cetirizine HCl | The Kroger Co. | NDA | Current |
| 30142-211 | All Day Allergy | Cetirizine HCl | The Kroger Co. | NDA | Current |
| 30142-211 | All Day Allergy | Cetirizine HCl | The Kroger Co. | NDA | Current |
| 30142-995 | Cetirizine HCl | Cetirizine HCl | KROGER COMPANY | NDA | Current |
| 30142-995 | Cetirizine HCl | Cetirizine HCl | KROGER COMPANY | NDA | Current |
| 30142-995 | Cetirizine HCl | Cetirizine HCl | KROGER COMPANY | NDA | Current |
| 36800-211 | All Day Allergy | Cetirizine HCl | TOP CARE (Topco Associates LLC) | NDA | Current |
| 36800-211 | All Day Allergy | Cetirizine HCl | TOP CARE (Topco Associates LLC) | NDA | Current |
| 37205-819 | All Day Allergy | Cetirizine HCl | Cardinal Health (Leader) 37205 | NDA | Current |
| 37808-211 | All Day Allergy | Cetirizine HCl | H E B | NDA | Current |
| 37808-211 | All Day Allergy | Cetirizine HCl | H E B | NDA | Current |
| 37808-211 | All Day Allergy | Cetirizine HCl | H E B | NDA | Current |
| 41163-219 | all day allergy | Cetirizine HCl | SUPERVALU INC | NDA | Current |
| 41520-211 | All Day Allergy | Cetirizine HCl | Care One (American Sales Company) | NDA | Current |
| 41520-211 | All Day Allergy | Cetirizine HCl | Care One (American Sales Company) | NDA | Current |
| 42507-211 | All Day Allergy | Cetirizine HCl | Hy-Vee | NDA | Current |
| 42507-211 | All Day Allergy | Cetirizine HCl | Hy-Vee | NDA | Current |
| 42507-211 | All Day Allergy | Cetirizine HCl | Hy-Vee | NDA | Current |
| 46122-613 | Cetirizine HCl | Cetirizine HCl | AMERISOURCE BERGEN | NDA | Current |
| 46122-613 | Cetirizine HCl | Cetirizine HCl | AMERISOURCE BERGEN | NDA | Current |
| 49035-711 | Allergy Relief | Cetirizine HCl | EQUATE (Wal-Mart Stores, Inc.) | NDA | Current |
| 49035-711 | Allergy Relief | Cetirizine HCl | EQUATE (Wal-Mart Stores, Inc.) | NDA | Current |
| 49035-711 | Allergy Relief | Cetirizine HCl | EQUATE (Wal-Mart Stores, Inc.) | NDA | Current |
| 49035-911 | Allergy Relief | Cetirizine HCl | EQUATE (Wal-Mart Stores, Inc.) | NDA | Current |
| 49035-911 | Allergy Relief | Cetirizine HCl | EQUATE (Wal-Mart Stores, Inc.) | NDA | Current |
| 49035-911 | Allergy Relief | Cetirizine HCl | EQUATE (Wal-Mart Stores, Inc.) | NDA | Current |
| 49738-211 | Cetirizine HCl | Cetirizine Hydrochloride | SMART SENSE (Kmart) | NDA | Current |
| 49738-211 | Cetirizine HCl | Cetirizine Hydrochloride | SMART SENSE (Kmart) | NDA | Current |
| 49738-211 | Cetirizine HCl | Cetirizine Hydrochloride | SMART SENSE (Kmart) | NDA | Current |
| 50580-779 | ZYRTEC | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-779 | ZYRTEC | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-779 | ZYRTEC | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 53943-219 | Allergy Relief | Cetirizine HCl | DISCOUNT DRUG MART, INC. | NDA | Current |
| 53943-219 | Allergy Relief | Cetirizine HCl | DISCOUNT DRUG MART, INC. | NDA | Current |
| 55312-211 | Allergy Relief | Cetirizine HCl | Western Family Foods, Inc. | NDA | Current |
| 55315-211 | All Day Allergy | Cetirizine HCl | Freds Inc | NDA | Current |
| 55315-211 | All Day Allergy | Cetirizine HCl | Freds Inc | NDA | Current |
| 56062-211 | Allergy Relief | Cetirizine HCl | Publix Supermarkets, Inc. | NDA | Current |
| 56062-211 | Allergy Relief | Cetirizine HCl | Publix Supermarkets, Inc. | NDA | Current |
| 56062-211 | Allergy Relief | Cetirizine HCl | Publix Supermarkets, Inc. | NDA | Current |
| 59726-211 | All Day Allergy | Cetirizine HCl | P & L Development, LLC | NDA | Current |
| 59726-212 | All Day Allergy Relief | Cetirizine HCl | P & L Development, LLC | NDA | Current |
| 59726-212 | All Day Allergy Relief | Cetirizine HCl | P & L Development, LLC | NDA | Current |
| 59726-212 | All Day Allergy Relief | Cetirizine HCl | P & L Development, LLC | NDA | Current |
| 59779-415 | Indoor/Outdoor ALLERGY RELIEF Softgels | Cetirizine Hydrochloride | CVS Pharmacy | NDA | Current |
| 63868-107 | All Day Allergy Relief | Cetirizine HCl | QUALITY CHOICE (Chain Drug Marketing Association) | NDA | Current |
| 63868-139 | All Day Allergy | Cetirizine HCl | QUALITY CHOICE (Chain Drug Marketing Association) | NDA | Current |
| 63868-139 | All Day Allergy | Cetirizine HCl | QUALITY CHOICE (Chain Drug Marketing Association) | NDA | Current |
| 63868-139 | All Day Allergy | Cetirizine HCl | QUALITY CHOICE (Chain Drug Marketing Association) | NDA | Current |
| 63868-433 | All Day Allergy Relief | Cetirizine HCl | CHAIN DRUG MARKETING ASSOCIATION INC. | NDA | Current |
| 63868-433 | All Day Allergy Relief | Cetirizine HCl | CHAIN DRUG MARKETING ASSOCIATION INC. | NDA | Current |
| 63868-433 | All Day Allergy Relief | Cetirizine HCl | CHAIN DRUG MARKETING ASSOCIATION INC. | NDA | Current |
| 63940-211 | Allergy Relief | Cetirizine HCl | Harmon Stores | NDA | Current |
| 63940-211 | Allergy Relief | Cetirizine HCl | Harmon Stores | NDA | Current |
| 68016-279 | All Day Allergy | Cetirizine Hydrochloride | Chain Drug Consortium, LLC | NDA | Current |
| 69452-265 | Cetirizine HCl | Cetirizine HCl | Bionpharma Inc. | NDA | Current |
| 69452-265 | Cetirizine HCl | Cetirizine HCl | Bionpharma Inc. | NDA | Current |
| 69452-265 | Cetirizine HCl | Cetirizine HCl | Bionpharma Inc. | NDA | Current |
| 69452-265 | Cetirizine HCl | Cetirizine HCl | Bionpharma Inc. | NDA | Current |
| 69842-911 | ALLERGY RELIEF | Cetirizine Hydrochloride | CVS Pharmacy | NDA | Current |
| 69842-911 | ALLERGY RELIEF | Cetirizine Hydrochloride | CVS Pharmacy | NDA | Current |
| 69842-911 | ALLERGY RELIEF | Cetirizine Hydrochloride | CVS Pharmacy | NDA | Current |