CETIRIZINE HYDROCHLORIDE
- Product NDC
- 55681-302
- 11-digit product format
- 556810302
- Labeler code
- 55681
- Product ID
- 55681-302_0e12b3c6-357a-b0dc-e063-6394a90a8ea4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CETIRIZINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TWIN MED, LLC
- Application
- ANDA209274
- Marketing category
- ANDA
- Marketing start
- 2022-03-02
- 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
- Brand name suffix
- 10 MG
- 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 |
|---|
| 55681-302-03 | CETIRIZINE HYDROCHLORIDE10 MG | 300 in 1 BOTTLE | TABLET | 300 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55681-302 | CETIRIZINE HYDROCHLORIDE 10 MG (CETIRIZINE HYDROCHLORIDE) TABLET [TWIN MED, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240104_d9437d88-da59-5567-e053-2995a90a362b.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 |
|---|
| 55681-302-03 | 55681030203 | 300 TABLET in 1 BOTTLE (55681-302-03) | 300 tablet | 2022-03-02 | 0000-00-00 | No | No | Current |