Cetirizine Hydrochloride
- Product NDC
- 43598-183
- 11-digit product format
- 435980183
- Labeler code
- 43598
- Product ID
- 43598-183_9b5f0b11-2f7f-0cb0-0ce7-c06c0b85c5c7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA078343
- Marketing category
- ANDA
- Marketing start
- 2018-12-17
- 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 |
|---|
| 43598-183-31 | Cetirizine Hydrochloride | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | | 2 |
| 43598-183-55 | Cetirizine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-183 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.] | 1 | Current NDC, 2 package rows | 20240522_206ab55a-3720-6205-d710-6e7953571418.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-183-31 | 43598018331 | 300 TABLET, FILM COATED in 1 BOTTLE (43598-183-31) | 2024-04-01 | No | No | Current |
| 43598-183-55 | 43598018355 | 500 TABLET, FILM COATED in 1 BOTTLE (43598-183-55) | 2023-11-01 | No | No | Current |