Medline
- Product NDC
- 53329-033
- 11-digit product format
- 533290033
- Labeler code
- 53329
- Product ID
- 53329-033_27d464c8-2b68-5598-e063-6394a90a7ad9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- cetirizine hcl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medline Industries, LP
- Application
- ANDA209274
- Marketing category
- ANDA
- Marketing start
- 2020-05-01
- Marketing end
- 2027-09-30
- 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
- Medline
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 |
|---|
| 53329-033-33 | Medline | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 53329-033-38 | Medline | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53329-033 | MEDLINE (CETIRIZINE HCL) TABLET [MEDLINE INDUSTRIES, LP] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241127_a75cd557-e19b-fdd4-e053-2a95a90a8097.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 |
|---|
| 53329-033-33 | 53329003333 | 30 TABLET in 1 BOTTLE (53329-033-33) | 30 tablet | 2020-05-01 | 0000-00-00 | No | No | Current |
| 53329-033-38 | 53329003338 | 90 TABLET in 1 BOTTLE (53329-033-38) | 90 tablet | 2020-05-01 | 0000-00-00 | No | No | Current |