Cetirizine HCl
- Product NDC
- 72657-128
- 11-digit product format
- 726570128
- Labeler code
- 72657
- Product ID
- 72657-128_9b19f466-3796-44b8-a637-092926c275f1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- GLENMARK THERAPEUTICS INC., USA
- Application
- ANDA078427
- Marketing category
- ANDA
- Marketing start
- 2024-05-13
- Substance
- CETIRIZINE HYDROCHLORIDE
- 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
- Cetirizine HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014676, 1014678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72657-128 | CETIRIZINE HCL (CETIRIZINE) TABLET CETIRIZINE HCL (CETIRIZINE) KIT [GLENMARK THERAPEUTICS INC., USA] | 5 | Current NDC, 36 package rows | 20250423_04b08c52-5390-4cdb-a9e7-fca81fffdc73.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72657-128-03 | 72657012803 | 1 BOTTLE in 1 CARTON (72657-128-03) / 300 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-04 | 72657012804 | 1 BOTTLE in 1 CARTON (72657-128-04) / 400 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-08 | 72657012808 | 1 BOTTLE in 1 CARTON (72657-128-08) / 120 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-14 | 72657012814 | 1 BOTTLE in 1 CARTON (72657-128-14) / 140 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-15 | 72657012815 | 1 BOTTLE in 1 CARTON (72657-128-15) / 150 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-18 | 72657012818 | 1 BOTTLE in 1 CARTON (72657-128-18) / 180 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-24 | 72657012824 | 1 BOTTLE in 1 CARTON (72657-128-24) / 240 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-30 | 72657012830 | 1 BOTTLE in 1 CARTON (72657-128-30) / 30 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-35 | 72657012835 | 1 BOTTLE in 1 CARTON (72657-128-35) / 365 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-41 | 72657012841 | 1 BOTTLE in 1 CARTON (72657-128-41) / 14 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-45 | 72657012845 | 1 BOTTLE in 1 CARTON (72657-128-45) / 45 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-60 | 72657012860 | 1 BOTTLE in 1 CARTON (72657-128-60) / 60 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-70 | 72657012870 | 1 BOTTLE in 1 CARTON (72657-128-70) / 70 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |
| 72657-128-81 | 72657012881 | 2 BOTTLE in 1 CARTON (72657-128-81) / 60 TABLET in 1 BOTTLE | 2 bottle | 2024-05-13 | No | No | Current |
| 72657-128-82 | 72657012882 | 2 BOTTLE in 1 CARTON (72657-128-82) / 70 TABLET in 1 BOTTLE | 2 bottle | 2024-05-13 | No | No | Current |
| 72657-128-84 | 72657012884 | 2 BOTTLE in 1 CARTON (72657-128-84) / 90 TABLET in 1 BOTTLE | 2 bottle | 2024-05-13 | No | No | Current |
| 72657-128-86 | 72657012886 | 2 BOTTLE in 1 CARTON (72657-128-86) / 120 TABLET in 1 BOTTLE | 2 bottle | 2024-05-13 | No | No | Current |
| 72657-128-90 | 72657012890 | 1 BOTTLE in 1 CARTON (72657-128-90) / 90 TABLET in 1 BOTTLE | 1 bottle | 2024-05-13 | No | No | Current |