levocetirizine dihydrochloride
- Product NDC
- 43598-735
- Requested package NDC
- 43598-735-79
- 11-digit product format
- 435980735
- Labeler code
- 43598
- Product ID
- 43598-735_febba1e2-723a-3f56-34bb-ef2278754ad6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA210375
- Marketing category
- ANDA
- Marketing start
- 2018-03-12
- 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 |
|---|---|---|---|---|---|---|---|
| A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 |
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 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210375-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2018-01-19 | f41ea6bd6efb… |
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
- 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 |
|---|---|
| 1f722b84-08de-7e6a-41ac-2c9d9bb9fb43 | 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 |
|---|---|---|---|---|---|---|
| 43598-735-04 | levocetirizine dihydrochloride | 1 in 1 CARTON | TABLET, COATED | 1 | 14 | |
| 43598-735-04 | levocetirizine dihydrochloride | 120 in 1 BOTTLE | TABLET, COATED | 120 | 14 | |
| 43598-735-22 | levocetirizine dihydrochloride | 55 in 1 BOTTLE | TABLET, COATED | 55 | 14 | |
| 43598-735-22 | levocetirizine dihydrochloride | 1 in 1 CARTON | TABLET, COATED | 1 | 14 | |
| 43598-735-30 | levocetirizine dihydrochloride | 1 in 1 CARTON | TABLET, COATED | 1 | 14 | |
| 43598-735-30 | levocetirizine dihydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | 14 | |
| 43598-735-35 | levocetirizine dihydrochloride | 35 in 1 BOTTLE | TABLET, COATED | 35 | 14 | |
| 43598-735-35 | levocetirizine dihydrochloride | 1 in 1 CARTON | TABLET, COATED | 1 | 14 | |
| 43598-735-58 | levocetirizine dihydrochloride | 10 in 1 BOTTLE | TABLET, COATED | 10 | 14 | |
| 43598-735-58 | levocetirizine dihydrochloride | 1 in 1 CARTON | TABLET, COATED | 1 | 14 | |
| 43598-735-79 | levocetirizine dihydrochloride | 2 in 1 CARTON | TABLET, COATED | 2 | 14 | |
| 43598-735-79 | levocetirizine dihydrochloride | 5 in 1 BLISTER PACK | TABLET, COATED | 5 | 14 | |
| 43598-735-80 | levocetirizine dihydrochloride | 80 in 1 BOTTLE | TABLET, COATED | 80 | 14 | |
| 43598-735-80 | levocetirizine dihydrochloride | 1 in 1 CARTON | TABLET, COATED | 1 | 14 | |
| 43598-735-90 | levocetirizine dihydrochloride | 90 in 1 BOTTLE | TABLET, COATED | 90 | 14 | |
| 43598-735-90 | levocetirizine dihydrochloride | 1 in 1 CARTON | TABLET, COATED | 1 | 14 | |
| 43598-735-95 | levocetirizine dihydrochloride | 200 in 1 BOTTLE | TABLET, COATED | 200 | 14 | |
| 43598-735-95 | levocetirizine dihydrochloride | 2 in 1 CARTON | TABLET, COATED | 2 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43598-735-30 | EA - Each | 43598-735 | f63cfcf2-4da8-499a-bfc3-df6f91d40e05 | 1 | 2024-09-09 |
| 43598-735-90 | EA - Each | 43598-735 | 9046de29-e000-4f9e-a13e-a7b3f0a92658 | 1 | 2024-09-09 |
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | 1f722b84-08de-7e6a-41ac-2c9d9bb9fb43 | 14 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | 1f722b84-08de-7e6a-41ac-2c9d9bb9fb43 | 14 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | 1f722b84-08de-7e6a-41ac-2c9d9bb9fb43 | 14 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | c8681ca3-27b4-6738-af72-599ff05f2ec8 | 13 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | c8681ca3-27b4-6738-af72-599ff05f2ec8 | 13 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | c8681ca3-27b4-6738-af72-599ff05f2ec8 | 13 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | 766b8836-74b8-8af7-b900-b813b4fc175b | 10 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | 766b8836-74b8-8af7-b900-b813b4fc175b | 10 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | 766b8836-74b8-8af7-b900-b813b4fc175b | 10 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | 6ba57f12-fd25-c4a6-ff2d-2955116f84c4 | 9 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | 7e933c85-96b0-b103-e26a-1aa8a1ded58e | 9 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | e1a6932b-d076-6573-5b88-7b06c3a91681 | 9 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | 6ba57f12-fd25-c4a6-ff2d-2955116f84c4 | 9 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | e1a6932b-d076-6573-5b88-7b06c3a91681 | 9 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | 7e933c85-96b0-b103-e26a-1aa8a1ded58e | 9 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | 6ba57f12-fd25-c4a6-ff2d-2955116f84c4 | 9 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | e1a6932b-d076-6573-5b88-7b06c3a91681 | 9 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | 7e933c85-96b0-b103-e26a-1aa8a1ded58e | 9 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | 82da5fa1-3633-2c48-32b9-d15482f308a1 | 8 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | 82da5fa1-3633-2c48-32b9-d15482f308a1 | 8 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | 82da5fa1-3633-2c48-32b9-d15482f308a1 | 8 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | e47658af-e0f3-5765-f568-300ba407dc29 | 6 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | b13ab6fc-4fec-c870-2c5f-b5e31dec722a | 6 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | e47658af-e0f3-5765-f568-300ba407dc29 | 6 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | b13ab6fc-4fec-c870-2c5f-b5e31dec722a | 6 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | b13ab6fc-4fec-c870-2c5f-b5e31dec722a | 6 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | e47658af-e0f3-5765-f568-300ba407dc29 | 6 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | fb0a3619-9d5b-5c58-82f3-31f031672f33 | 4 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1 | 4 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | 5036170d-7eeb-65a8-8473-7d98aeb51ee4 | 4 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1 | 4 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | fb0a3619-9d5b-5c58-82f3-31f031672f33 | 4 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | 5036170d-7eeb-65a8-8473-7d98aeb51ee4 | 4 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | 5036170d-7eeb-65a8-8473-7d98aeb51ee4 | 4 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | fb0a3619-9d5b-5c58-82f3-31f031672f33 | 4 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1 | 4 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | 61fb8bef-d868-adee-3237-d3268d603ba6 | 3 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | 0216f644-767c-ae88-f48f-cd29ac1547ed | 3 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | fafc8149-d59a-1253-ae79-f33a088e3769 | 3 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | 0216f644-767c-ae88-f48f-cd29ac1547ed | 3 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | fafc8149-d59a-1253-ae79-f33a088e3769 | 3 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | 61fb8bef-d868-adee-3237-d3268d603ba6 | 3 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | fafc8149-d59a-1253-ae79-f33a088e3769 | 3 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | 61fb8bef-d868-adee-3237-d3268d603ba6 | 3 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | 0216f644-767c-ae88-f48f-cd29ac1547ed | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43598-735-79 | 43598073579 | 2 BLISTER PACK in 1 CARTON (43598-735-79) / 5 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2018-04-17 | 0000-00-00 | No | No | Current |