levocetirizine dihydrochloride
- Product NDC
- 43598-735
- 11-digit product format
- 435980735
- Labeler code
- 43598
- Product ID
- 43598-735_0b6d0486-2682-21fe-de0a-72d69a4b32c9
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- levocetirizine dihydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | SOD6A38AGA |
| Rxcui | 855172 |
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#
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 |
|---|---|---|---|---|---|---|---|---|
| 43598-735-04 | 43598073504 | 1 BOTTLE in 1 CARTON (43598-735-04) / 120 TABLET, COATED in 1 BOTTLE | 1 bottle | 2020-02-15 | No | No | Historical | |
| 43598-735-22 | 43598073522 | 1 BOTTLE in 1 CARTON (43598-735-22) / 55 TABLET, COATED in 1 BOTTLE | 1 bottle | 2018-03-12 | 0000-00-00 | No | No | Current |
| 43598-735-30 | 43598073530 | 1 BOTTLE in 1 CARTON (43598-735-30) / 30 TABLET, COATED in 1 BOTTLE | 1 bottle | 2018-08-20 | No | No | Historical | |
| 43598-735-35 | 43598073535 | 1 BOTTLE in 1 CARTON (43598-735-35) / 35 TABLET, COATED in 1 BOTTLE | 1 bottle | 2018-03-12 | 0000-00-00 | No | No | Current |
| 43598-735-58 | 43598073558 | 1 BOTTLE in 1 CARTON (43598-735-58) / 10 TABLET, COATED in 1 BOTTLE | 1 bottle | 2025-07-30 | No | No | Historical | |
| 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 |
| 43598-735-80 | 43598073580 | 1 BOTTLE in 1 CARTON (43598-735-80) / 80 TABLET, COATED in 1 BOTTLE | 1 bottle | 2018-03-12 | 0000-00-00 | No | No | Current |
| 43598-735-90 | 43598073590 | 1 BOTTLE in 1 CARTON (43598-735-90) / 90 TABLET, COATED in 1 BOTTLE | 1 bottle | 2018-08-20 | No | No | Historical | |
| 43598-735-95 | 43598073595 | 2 BOTTLE in 1 CARTON (43598-735-95) / 200 TABLET, COATED in 1 BOTTLE | 2 bottle | 2023-10-27 | No | No | Historical |