cetirizine hydrochloride
- Product NDC
- 62011-0414
- 11-digit product format
- 620110414
- Labeler code
- 62011
- Product ID
- 62011-0414_8d9819f5-2652-d4ce-3972-027929fb025b
- 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
- 2019-11-12
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 62011-0414 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 62011-0414 | 62011-0414-1 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 62011-0414 | 62011-0414-2 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 62011-0414 | 62011-0414-3 | D | Discontinued by firm | 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.
| 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 | 62011-0414-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 62011-0414-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 62011-0414-2 | 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 | 62011-0414-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 62011-0414-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 62011-0414-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 62011-0414-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 62011-0414-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 62011-0414-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 62011-0414-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 62011-0414-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 62011-0414-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 62011-0414-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 62011-0414-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 62011-0414-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 62011-0414-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 62011-0414-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 62011-0414-2 | cdf11ea48f46… | ba0047e9e063… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | d8e5a09893c0… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62011-0414-1 | EA - Each | 62011-0414 | ddf0f908-7456-4e65-b163-aa5157cbedb5 | 1 | 2021-06-02 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 62011-0414 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC] | 5 | Legacy NDC | 20241025_00b01fa8-2533-ff93-bd13-ca472c46bb94.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 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62011-0414-1 | 62011041401 | 1 BOTTLE in 1 CARTON (62011-0414-1) > 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-11-12 | 0000-00-00 | No | No | Current |
| 62011-0414-2 | 62011041402 | 1 BOTTLE in 1 CARTON (62011-0414-2) > 60 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-11-12 | 0000-00-00 | No | No | Current |
| 62011-0414-3 | 62011041403 | 1 BOTTLE in 1 CARTON (62011-0414-3) > 90 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-11-12 | 0000-00-00 | No | No | Current |