CETIRIZINE HYDROCHLORIDE
- Product NDC
- 69452-465
- 11-digit product format
- 694520465
- Labeler code
- 69452
- Product ID
- 69452-465_45745bf3-a132-b51a-e063-6394a90a712e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CETIRIZINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA078862
- Marketing category
- ANDA
- Marketing start
- 2024-10-20
- 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 |
|---|
| 69452-465-81 | CETIRIZINE HYDROCHLORIDE | 400 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 400 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-465 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [BIONPHARMA INC.] | 1 | Current NDC, 1 package rows | 20241021_831d4141-b3be-4d98-a372-9c4d57ad296c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69452-465-81 | 69452046581 | 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-465-81) | 2024-10-20 | No | No | Current |