Cetirizine hydrochloride
- Product NDC
- 69729-139
- 11-digit product format
- 697290139
- Labeler code
- 69729
- Product ID
- 69729-139_18ab8b3c-80f1-72ea-e063-6394a90ac0d1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- ANDA209274
- Marketing category
- ANDA
- Marketing start
- 2020-07-01
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69729-139-14 | Cetirizine hydrochloride | 14 in 1 BOTTLE | TABLET | 14 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69729-139 | CETIRIZINE HYDROCHLORIDE TABLET [OPMX LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240518_b452bca6-2c51-d0a1-e053-2995a90aff67.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69729-139-14 | 69729013914 | 14 TABLET in 1 BOTTLE (69729-139-14) | 14 tablet | 2020-07-01 | 0000-00-00 | No | No | Current |