CETIRIZINE HYDROCHLORIDE
- Product NDC
- 13668-030
- 11-digit product format
- 136680030
- Labeler code
- 13668
- Product ID
- 13668-030_d73115c6-4b1b-46c9-90f6-94adf9a342e3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CETIRIZINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA079191
- Marketing category
- ANDA
- Marketing start
- 2010-04-15
- Marketing end
- 0000-00-00
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 | 13668-030 | D | Discontinued by firm | 2026-08-03 | ||
| excluded product | product | 13668-030 | D | Discontinued by firm | 2026-08-03 | ||
| excluded product | product | 13668-030 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 13668-030 | 13668-030-01 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 13668-030 | 13668-030-05 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 13668-030 | 13668-030-25 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 13668-030 | 13668-030-30 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 13668-030 | 13668-030-02 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 13668-030 | 13668-030-03 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 13668-030 | 13668-030-04 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 13668-030 | 13668-030-06 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 13668-030 | 13668-030-01 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 13668-030 | 13668-030-05 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 13668-030 | 13668-030-25 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 13668-030 | 13668-030-30 | D | Discontinued by firm | 2026-08-03 |
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 product | product | d630ba8d3edf… | 732f749b63fb… | |
| 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 | 13668-030-06 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 13668-030-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 13668-030-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 13668-030-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 13668-030-25 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 13668-030-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 13668-030-25 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 13668-030-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 13668-030-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 13668-030-03 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 13668-030-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 13668-030-01 | 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 product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 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 | 13668-030-06 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13668-030-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13668-030-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13668-030-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13668-030-25 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13668-030-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13668-030-25 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13668-030-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13668-030-05 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13668-030-03 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13668-030-05 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13668-030-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13668-030-06 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13668-030-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13668-030-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13668-030-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13668-030-25 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13668-030-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13668-030-25 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13668-030-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13668-030-05 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13668-030-03 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13668-030-05 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13668-030-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13668-030-06 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13668-030-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13668-030-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13668-030-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13668-030-25 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13668-030-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13668-030-25 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13668-030-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13668-030-05 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13668-030-03 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13668-030-05 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13668-030-01 | a1b67e2a42f9… | c4cf2c586c0d… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079191-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2010-04-15 | ||
| A079191-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2010-04-15 | ||
| A079191-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2010-04-15 | ||
| A079191-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2010-04-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A079191-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-04-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079191-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-04-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079191-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-04-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079191-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-04-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079191-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-04-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079191-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-04-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079191-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-04-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079191-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-04-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079191-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-04-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079191-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-04-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079191-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-04-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079191-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-04-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079191-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-04-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079191-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-04-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079191-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-04-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079191-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-04-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079191-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-04-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079191-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-04-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079191-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-04-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079191-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-04-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079191-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-04-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079191-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-04-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079191-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-04-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079191-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-04-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079191-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-04-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079191-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-04-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079191-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-04-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079191-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-04-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079191-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-04-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079191-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-04-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079191-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-04-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079191-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-04-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079191-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-04-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079191-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-04-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079191-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-04-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079191-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-04-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079191-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-04-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079191-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-04-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079191-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-04-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079191-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-04-15 | d06236e962d9… |