cetirizine hydrochloride
- Product NDC
- 72789-343
- 11-digit product format
- 727890343
- Labeler code
- 72789
- Product ID
- 72789-343_14aac962-74bc-8515-e063-6294a90aea85
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078336
- Marketing category
- ANDA
- Marketing start
- 2007-12-27
- 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 |
|---|
| 72789-343-10 | cetirizine hydrochloride | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | | 7 |
| 72789-343-30 | cetirizine hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 7 |
| 72789-343-90 | cetirizine hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-343 | CETIRIZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | Current NDC, 3 package rows | 20240328_af7513ae-5107-477c-a7da-0ded9d53a55c.zip |
| 72789-343 | CETIRIZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | Current NDC | 20241019_03c0a599-072a-10ef-e063-6394a90a9698.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 |
|---|
| 72789-343-10 | 72789034310 | 10 TABLET in 1 BOTTLE, PLASTIC (72789-343-10) | 10 tablet | 2024-03-27 | No | No | Current |
| 72789-343-30 | 72789034330 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-343-30) | 30 tablet | 2023-08-16 | No | No | Current |
| 72789-343-90 | 72789034390 | 90 TABLET in 1 BOTTLE, PLASTIC (72789-343-90) | 90 tablet | 2023-08-16 | No | No | Current |