Cetirizine hydrochloride
- Product NDC
- 62207-764
- 11-digit product format
- 622070764
- Labeler code
- 62207
- Product ID
- 62207-764_2432f862-6d80-666d-e063-6294a90acf74
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Granules India Ltd
- Application
- ANDA209274
- Marketing category
- ANDA
- Marketing start
- 2018-05-28
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 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 hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62207-764-49 | Cetirizine hydrochloride | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 10 |
| 62207-764-55 | Cetirizine hydrochloride | 14 in 1 BOTTLE | TABLET, COATED | 14 | | 10 |
| 62207-764-73 | Cetirizine hydrochloride | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | | 10 |
| 62207-764-73 | Cetirizine hydrochloride | 13 in 1 CARTON | TABLET, COATED | 13 | | 10 |
| 62207-764-30 | Cetirizine hydrochloride | 20000 in 1 POUCH | TABLET, COATED | 20000 | | 3 |
| 62207-764-88 | Cetirizine hydrochloride | 100000 in 1 BOX | TABLET, COATED | 100000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62207-764 | CETIRIZINE HYDROCHLORIDE TABLET, COATED [GRANULES INDIA LTD] | 10 | Current NDC, Legacy NDC, 4 package rows | 20241016_6efd5a60-e281-43f9-a52c-a95f46fbcbfc.zip |
| 62207-764 | CETIRIZINE HYDROCHLORIDE TABLET, COATED [GRANULES INDIA LTD] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230219_6e5bdf93-d96b-19bc-e053-2a91aa0ad94d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62207-764-30 | 62207076430 | 20000 in 1 POUCH | | | | | | Historical |
| 62207-764-49 | 62207076449 | 1000 TABLET, COATED in 1 BOTTLE (62207-764-49) | | 2018-05-28 | 0000-00-00 | No | No | Current |
| 62207-764-54 | 62207076454 | 14 TABLET, COATED in 1 BOTTLE (62207-764-54) | | 2018-05-28 | 0000-00-00 | No | No | Current |
| 62207-764-55 | 62207076455 | 14 TABLET, COATED in 1 BOTTLE (62207-764-55) | | 2018-05-28 | 0000-00-00 | No | No | Current |
| 62207-764-73 | 62207076473 | 13 BLISTER PACK in 1 CARTON (62207-764-73) / 10 TABLET, COATED in 1 BLISTER PACK | 13 blister pack | 2018-05-28 | | No | No | Historical |
| 62207-764-88 | 62207076488 | 100000 in 1 BOX | | | | | | Historical |