Cetirizine Hydrochloride
- Product NDC
- 81469-353
- 11-digit product format
- 814690353
- Labeler code
- 81469
- Product ID
- 81469-353_5c9ebb06-784f-4ef7-e063-6394a90aaf25
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- First Nation Group, LLC
- Application
- ANDA076047
- Marketing category
- ANDA
- Marketing start
- 2026-05-29
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2007-12-27 | ||
| A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2007-12-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076047-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076047-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 74a2ff9319b5… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetirizine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
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 Hydrochloride | CETIRIZINE HYDROCHLORIDE | First Nation Group, LLC | 5267f7c0-e62f-35da-e063-6394a90a9346 | 2026-06-03 | Warnings | 076047 ANDA076047 81469-353 |
| Dr Simi Cetirizine Hydrochloride 10 mg | CETIRIZINE HYDROCHLORIDE 10 MG | Farmacias De Similares TX LLC | 48d835d7-5c99-0bd6-e063-6394a90a61ba | 2026-01-20 | Warnings | 076047 ANDA076047 |
| cetirizine hydrochloride | CETIRIZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 03c0a599-072a-10ef-e063-6394a90a9698 | 2025-11-20 | Warnings | 076047 ANDA076047 |
| Cetirizine Hydrochloride 10 mg | CETIRIZINE HYDROCHLORIDE 10 MG | Contract Pharmacal Corp. | 84459f11-3405-4a8e-be38-333b7de2a578 | 2025-05-28 | Warnings | 076047 ANDA076047 |
| Cetirizine HCl | CETIRIZINE | GERI-CARE PHARMACEUTICAL CORP | 3389e947-b7d1-6caf-e063-6294a90a2238 | 2025-04-24 | Warnings | 076047 ANDA076047 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 81469-353-01 | 81469035301 | 100 TABLET in 1 BOTTLE (81469-353-01) | 100 tablet | 2026-06-01 | No | No | Current |
| 81469-353-03 | 81469035303 | 300 TABLET in 1 BOTTLE (81469-353-03) | 300 tablet | 2026-06-01 | No | No | Current |
| 81469-353-05 | 81469035305 | 500 TABLET in 1 BOTTLE (81469-353-05) | 500 tablet | 2026-06-01 | No | No | Current |
| 81469-353-90 | 81469035390 | 90 TABLET in 1 BOTTLE (81469-353-90) | 90 tablet | 2026-06-01 | No | No | Current |