cetirizine hydrochloride
- Product NDC
- 70677-1007
- Requested package NDC
- 70677-1007-4
- 11-digit product format
- 706771007
- Labeler code
- 70677
- Product ID
- 70677-1007_b13a3e2a-c087-727c-8d9e-90faa85292e6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Strategic Sourcing Services LLC
- Application
- ANDA078343
- Marketing category
- ANDA
- Marketing start
- 2022-05-12
- Marketing end
- 2027-02-28
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2008-01-15 | ||
| A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2008-01-15 | ||
| A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2008-01-15 | ||
| A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2008-01-15 |
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 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 5bbf6a4d5a75… |
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
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 64O047KTOA | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1014678 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 52b70885-f623-b1c8-29c6-584bff46ed45 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70677-1007-1 | cetirizine hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 | |
| 70677-1007-1 | cetirizine hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 70677-1007-2 | cetirizine hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 3 | |
| 70677-1007-2 | cetirizine hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 70677-1007-3 | cetirizine hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 70677-1007-3 | cetirizine hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 3 | |
| 70677-1007-4 | cetirizine hydrochloride | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | 3 | |
| 70677-1007-4 | cetirizine hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70677-1007-1 | EA - Each | 70677-1007 | b030d00d-b5a2-41f3-b8d9-69b9d5fe0964 | 1 | 2023-09-05 |
| 70677-1007-2 | EA - Each | 70677-1007 | f5b098e3-a1e4-4d49-b3f7-1adfe8889e68 | 1 | 2023-09-05 |
| 70677-1007-3 | EA - Each | 70677-1007 | f68a27ec-df80-442a-948e-f5887ac01030 | 1 | 2023-09-05 |
| 70677-1007-4 | EA - Each | 70677-1007 | c77cd805-0611-4779-b839-da528a00ac87 | 1 | 2023-09-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70677-1007 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC] | 1 | Current NDC, 8 package rows | 20230422_52b70885-f623-b1c8-29c6-584bff46ed45.zip |
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 TABLETS | Preferred Pharmaceuticals Inc. | 14a885e5-5e75-4a18-b5bc-6aaa748712db | 2026-03-25 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Proficient Rx LP | 55b1738c-fa72-4cd1-a8e8-be41b12b593d | 2026-03-01 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Sportpharm LLC | d5297bdb-823c-4318-a797-5311d5cf0df8 | 2026-02-06 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Northwind Health Company, LLC | f70886af-a8a4-63a0-e053-6294a90a2d2c | 2026-01-01 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | VERITYRX, LLC | 42778a1c-6894-8646-e063-6294a90a6cb5 | 2025-10-31 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Bryant Ranch Prepack | e4324124-13f8-4450-9fd6-686bd6e25578 | 2025-10-28 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Dr. Reddy's Laboratories Inc. | 206ab55a-3720-6205-d710-6e7953571418 | 2025-07-17 | Warnings | 078343 ANDA078343 |
| cetirizine hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Strategic Sourcing Services LLC | 52b70885-f623-b1c8-29c6-584bff46ed45 | 2025-07-17 | Warnings | 078343 ANDA078343 70677-1007-4 70677-1007 70677100704 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Discount Drug Mart, Inc | c7c7e496-3682-c764-88ef-d2a09823f71e | 2025-07-16 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Dr. Reddy's Laboratories Inc. | e4eca4df-9ad8-b7c4-b512-bfaed5673789 | 2025-07-16 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Dr.Reddy's Laboratories Limited | de152651-bfcd-856a-8329-a2ac93a376bc | 2011-09-30 | Warnings | 078343 ANDA078343 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | 52b70885-f623-b1c8-29c6-584bff46ed45 | 3 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | 52b70885-f623-b1c8-29c6-584bff46ed45 | 3 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | 52b70885-f623-b1c8-29c6-584bff46ed45 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70677-1007-4 | 70677100704 | 1 BOTTLE in 1 CARTON (70677-1007-4) / 300 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2023-05-05 | 2027-02-28 | No | No | Historical |