Indoor and Outdoor Allergy Relief
- Product NDC
- 87509-0002
- 11-digit product format
- 875090002
- Labeler code
- 87509
- Product ID
- 87509-0002_4d50d76d-12e9-17c0-e063-6394a90a4f6f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine HCl
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Famora Inc.
- Application
- ANDA077829
- Marketing category
- ANDA
- Marketing start
- 2026-03-18
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Indoor and Outdoor Allergy Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 87509-0002-3 | Indoor and Outdoor Allergy Relief | 365 in 1 BOTTLE | TABLET, COATED | 365 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 87509-0002-3 | 87509000203 | 365 TABLET, COATED in 1 BOTTLE (87509-0002-3) | 2026-03-18 | No | No | Current |