Cetirizine HCl
- Product NDC
- 80136-856
- 11-digit product format
- 801360856
- Labeler code
- 80136
- Product ID
- 80136-856_0647ef67-e7f9-a73e-e063-6294a90abe76
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine HCl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northeast Pharma
- Application
- NDA022429
- Marketing category
- NDA
- Marketing start
- 2023-09-26
- 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 HCl
- 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 | 1014675 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80136-856-23 | Cetirizine HCl | 25 in 1 BOTTLE, PLASTIC | CAPSULE | 25 | | 1 |
| 80136-856-23 | Cetirizine HCl | 1 in 1 CARTON | CAPSULE | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80136-856 | CETIRIZINE HCL CAPSULE [NORTHEAST PHARMA] | 1 | Current NDC, 2 package rows | 20230928_0647ef4c-8912-9f44-e063-6294a90ae3a6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80136-856-23 | 80136085623 | 1 BOTTLE, PLASTIC in 1 CARTON (80136-856-23) / 25 CAPSULE in 1 BOTTLE, PLASTIC | 2023-09-26 | No | No | Historical |