levocetirizine dihydrochloride
- Product NDC
- 51655-564
- 11-digit product format
- 516550564
- Labeler code
- 51655
- Product ID
- 51655-564_4b4903ae-48bd-d41a-e063-6294a90ac4ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA203646
- Marketing category
- ANDA
- Marketing start
- 2021-01-25
- Substance
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Active strength
- 5 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 |
|---|---|---|---|---|---|---|---|
| A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203646-001 | AB |
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 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203646-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-09-09 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203646-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203646-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203646-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203646-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203646-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203646-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203646-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203646-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203646-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203646-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203646-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203646-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203646-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203646-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203646-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203646-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203646-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A203646-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A203646-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203646-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203646-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A203646-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A203646-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A203646-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A203646-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A203646-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A203646-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203646-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A203646-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A203646-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203646-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203646-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203646-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203646-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A203646-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A203646-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203646-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A203646-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A203646-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203646-001 | AB | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- levocetirizine dihydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOD6A38AGA | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 855172 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dae403cd-b6fc-7c50-e053-2995a90a95e3 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 36cf9111-9cc4-8f59-a74c-0c1cfbd4a760 | Product name | 7 | 20190702 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51655-564-52 | levocetirizine dihydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 5 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Bryant Ranch Prepack | 8274ca80-e7d3-4f4f-9901-cc5c589b4fef | 2026-05-21 | Warnings, Adverse reactions | 203646 ANDA203646 |
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Bryant Ranch Prepack | be58ca52-ab5d-4656-bfe0-bd5766235968 | 2026-05-15 | Warnings, Adverse reactions | 203646 ANDA203646 |
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Bryant Ranch Prepack | c79d3668-5243-4627-ad2b-cc7c045df120 | 2026-03-31 | Warnings, Adverse reactions | 203646 ANDA203646 |
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | c2dbf151-5b3d-5dfb-e053-2995a90a4c19 | 2026-03-25 | Warnings, Adverse reactions | 203646 ANDA203646 |
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Northwind Health Company, LLC | dae403cd-b6fc-7c50-e053-2995a90a95e3 | 2026-01-01 | Warnings, Adverse reactions | 203646 ANDA203646 51655-564 |
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Golden State Medical Supply, Inc. | 163dcce7-4535-a596-e063-6394a90a634f | 2025-12-11 | Warnings, Adverse reactions | 203646 ANDA203646 |
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | ScieGen Pharmaceuticals, Inc. | bd7fe481-dfe7-4dfd-aa05-6e2318a9234e | 2025-10-16 | Warnings, Adverse reactions | 203646 ANDA203646 |
| Levocetirizine Dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Westminster Pharmaceuticals, LLC | 85dcd6c0-7fb2-40b3-b07f-93bab169011d | 2025-09-30 | Warnings, Adverse reactions | 203646 ANDA203646 |
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 8f308352-5854-409e-8bf7-bc9958cc3c5e | 2025-07-14 | Warnings, Adverse reactions | 203646 ANDA203646 |
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 51d88b2a-d10d-4e7a-b874-98de48069223 | 2025-02-21 | Warnings, Adverse reactions | 203646 ANDA203646 |
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Bryant Ranch Prepack | 4d0a0f8e-b298-46d2-b27d-0bb737507fed | 2024-04-12 | Warnings, Adverse reactions | 203646 ANDA203646 |
| Levocetirizine Dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Proficient Rx LP | 7108ad0a-af1e-4172-b4ba-e5d9aaadfba7 | 2022-10-01 | Warnings, Adverse reactions | 203646 ANDA203646 |
| Levocetirizine Dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Proficient Rx LP | 1ceff0e6-1e66-4494-b986-1bd23eb6813e | 2022-03-01 | Warnings, Adverse reactions | 203646 ANDA203646 |
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Proficient Rx LP | b84ccb27-9c52-43b9-9a46-8f52a571045e | 2019-11-01 | Warnings, Adverse reactions | 203646 ANDA203646 |
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Bryant Ranch Prepack | 34541530-ae3b-4247-b08c-cd1c13e2e6a1 | 2019-06-11 | Warnings, Adverse reactions | 203646 ANDA203646 |
| levocetirizine dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Vensun Pharmaceuticals, Inc. | 7a2ca8aa-ba0b-45b4-bdb3-651879350130 | 2018-07-13 | Warnings, Adverse reactions | 203646 ANDA203646 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | dae403cd-b6fc-7c50-e053-2995a90a95e3 | 5 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | dae403cd-b6fc-7c50-e053-2995a90a95e3 | 5 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | dae403cd-b6fc-7c50-e053-2995a90a95e3 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51655-564-52 | 51655056452 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-564-52) | 30 tablet | 2021-01-25 | No | No | Current |